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Balanced Health Products
(212)794-9793
FOR IMMEDIATE RELEASE -- December 8, 2008 -- Balanced Health Products, Inc. has expanded its voluntarily recall of STARCAPS DIET SYSTEM DIETARY SUPPLEMENT to include additional Lot Numbers 12/2009 – 82866 and 12/2010 - 83801, sold in 30 capsule plastic bottles.
The recall is effective immediately and is being undertaken because these lots of STARCAPS contain an undeclared drug ingredient- Bumetanide – a diuretic available by prescription only. Bumetanide is also not listed on the product label as an ingredient in this product.
Bumetanide is a diuretic indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease including nephrotic syndrome. Bumetanide has been detected in STARCAPS at a level of 0.8mg per capsule. Potential risks associated with the use of Bumetanide include serious and significant fluid and electrolyte loss and an elevation in uric acid concentrations. Consumers should not take Bumetanide if they are allergic to sulfonamides. Significant drug interactions with Bumetanide, such as with digoxin and lithium, may lead to an increase risk of toxicity. Patients may also be at an increased risk of hypotension (low blood pressure), fainting (syncope) and resultant injury if they have normal blood pressure or are already taking an antihypertensive medication and take STARCAPS with undeclared Bumetanide.
The company has received no reports of illness associated with this product.
The company’s investigation to date has indicated that an additional lot of raw material intended for use in the production of STARCAPS which has been stored in sealed drums since the time of its importation into the U.S. is also contaminated with Bumetanide. This information seems to indicate that the contamination occurred at the point of production of the raw material in Lima, Peru.
STARCAPS lot number 12/2009 – 82866, totaling 28,739 consumer-size bottles was distributed nationwide from 3/2006 to 4/2007 through retail outlets and online sales.
STARCAPS lot number 12/2010 - 83801, totaling 28,530 consumer-size bottles was distributed nationwide from 5/2007 to 7/2008 through retail outlets and online sales.
Consumers who purchased STARCAPS Lot Numbers 12/2009 – 82866 and 12/2010 – 83801 should immediately discontinue their use and return it to Balanced Health Products, Inc. at the address on the product label.
Consumers with questions may contact the company at (212) 794-9793 from 10:30am to 4pm EST Monday through Friday.
Consumers who experience adverse events with any lots of this product should seek immediate help from their physician or healthcare provider.
Retail stores are being notified by fax or registered mail to immediately stop all sales and return product to the company.
This recall is being made in cooperation with the US Food and Drug Administration.
FOR IMMEDIATE RELEASE -- November 7, 2008, Glendale, CA -- Nestlé USA is voluntarily recalling two (2) production codes of Nestlé Nesquik Strawberry Powder 21.8 ounce that may contain small fragments of aluminum.
The recall only includes two (2) production codes of 21.8-ounce containers of Nestlé Nesquik Strawberry Powder. Printed on the bottom of each plastic container is a production code of "82255880" or "82265880" with a best by date of "August 2010."
No other Nestlé Nesquik products or production codes of Nestlé Nesquik Strawberry Powder are affected by this recall.
The products were produced on August 12
and 13 and were distributed in the U.S. and in Puerto Rico.
Consumers who have this product at home can return it to the store where it was
purchased for a refund.
Consumers with questions about the recall should call Nestlé Consumer Services Center at 888-637-4345.
Nestlé apologizes for any inconvenience experienced by our valued consumers and retail customers
FOR IMMEDIATE RELEASE -- October 22, 2008 -- Harry and David, of Medford, Oregon, is voluntarily recalling approximately 400 1 lb. 4 oz. boxes labeled Harry & David Moose Munch Confection, Milk Chocolate Gingerbread because the package may contain a different Moose Munch product which contains pecans not declared on the ingredient statement. People who have an allergy or severe sensitivity to pecans run the risk of serious or life-threatening allergic reaction if they consume this product.
Affected product was distributed throughout the United States under the Harry & David brand only in Harry and David stores.
Harry and David is recalling 1 lb. 4 oz. boxes of Harry & David Moose Munch Confection, Milk Chocolate with a "Best if used by" date of 06/28/09. The "Best if used by" date is located on a sticker on the bottom of the box. The bottom of the box also has the stock identifying number RSD142014 printed on it. This lot of product was sold beginning 10/09/08. The popcorn-based confection is packaged in 1 lb. 4 oz. brown and white paperboard boxes. The boxes have a slight wedge shape and feature a large white moose image on the front. Inside the boxes are clear plastic bags of the confection.
There have been no illnesses or injuries reported to date. Anyone concerned about an illness/injury should contact a physician immediately.
This problem, which was discovered on October 21st, 2008, occurred because Dark Chocolate Butter Pecan Moose Munch® Confection was inadvertently packed in a Milk Chocolate Gingerbread outer box. It is estimated that fewer than 60 such boxes were produced.
Consumers with product may return it to any Harry and David retail store for a full refund. Consumers with questions about the recalled product may phone the Harry and David Customer Service division at 800-233-1101, 24 hours a day.
FOR IMMEDIATE RELEASE -- October 6, 2008 -- New York State Agriculture Commissioner Patrick Hooker today alerted consumers not to eat “Frozen Salted Croaker” distributed by YS Trading Corp of 38-21 23rd Street, Long Island City, New York 11101 because the product was uneviscerated.
The "Frozen Salted Croaker" was sold in Hicksville, New York, Flushing, New York, and New Jersey in un-coded, unlabeled plastic bags.
Uneviscerated fish is prohibited under New York State Department of Agriculture and Markets’ regulations because Clostridium botulinum spores are more likely to be concentrated in the viscera than any other portion of the fish. Uneviscerated fish has been linked to outbreaks of Botulism poisoning.
Because the fish is uneviscerated, the product may become contaminated with Clostridium botulinum spores, which can cause Botulism, a serious and potentially fatal food-borne illness. Symptoms of Botulism include blurred or double vision, general weakness, poor reflexes, difficulty swallowing and respiratory paralysis.
The "Frozen Salted Croaker" was found by a New York State Department of Agriculture and Markets food inspector during a routine inspection. Subsequent analysis by New York State Food Laboratory personnel confirmed the product to be uneviscerated.
No illnesses have been reported to date in connection with the product. Consumers who have this product are advised not to eat it.
FOR IMMEDIATE RELEASE -- September 22, 2008 -- Fine Land Corp of 239 Bay 20th Street, Brooklyn, NY 11214, is recalling Ying Feng Foodstuffs Brand Pumpkin Seeds because it contains undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.
Ying Feng Foodstuffs Brand Pumpkin Seeds is sold in a 10 ounce, clear plastic package with the following code: EXP 03 25 2010 and was distributed nationwide. It is a product of China.
The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of sulfites in Ying Feng Foodstuffs Brand Pumpkin Seeds which were not declared on the label. The consumption of 10 milligrams of sulfites per serving has been reported to elicit severe reactions in some asthmatics. Anaphylactic shock could occur in certain sulfite sensitive individuals upon ingesting 10 milligrams or more of sulfites.
No illnesses or allergic reactions involving this product has been reported to date. Consumers who have purchased Ying Feng Foodstuffs Brand Pumpkin Seeds are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at 718-714-1850
On September 12, 2008, in light of reports from China of melamine contaminated infant formula, the FDA issued a Health Information Advisory to proactively reassure the American public that there is no known threat of contamination in infant formula manufactured by companies that have met the requirements to sell such products in the United States. That advisory also warned members of Chinese communities in the United States that infant formula manufactured in China, possibly available for purchase at Asian markets, could pose a risk to infants.
The FDA had contacted the companies who manufacture infant formula for distribution in the United States and received information from the companies that they are not importing formula or source materials from China.
At the same time, the FDA—in conjunction with state and local officials—began a nation-wide investigation to check Asian markets for Chinese manufactured infant formula that may have been brought into the United States. In particular, this effort focused on areas of the country with large Chinese communities, such as Los Angeles, San Francisco, Seattle and New York. To date, investigators have visited more than 1,000 retail markets and have not found Chinese infant formula present on shelves in these markets.
In addition, the FDA is advising consumers not to purchase infant formula manufactured in China from internet sites or from other sources.
FDA has taken, and will continue to take, proactive measures to help ensure the safety of the American food supply. In conjunction with state and local officials, FDA will continue to check retail stores for food items imported from China that could contain a significant amount of milk or milk proteins. Additionally, FDA is sampling and testing milk and milk-derived ingredients and finished food products that could contain these ingredients from Chinese sources. Milk-derived ingredients include whole milk powder, non-fat milk powder, whey powder, lactose powder, and casein. This sampling and testing is done when these ingredients or products are imported into the United States or found during visits to Asian markets. If the products are adulterated because they contain melamine and/or a melamine analog, FDA will take action to prevent the products from entering the U.S. food supply.
In addition to state and local governments, FDA is working in close cooperation with Customs and Border Protection within the U.S. Department of Homeland Security, the U.S. Department of Agriculture, other federal agencies, and foreign governments.
FOR IMMEDIATE RELEASE -- September 15, 2008 --- Ralston Foods, Division of Ralcorp Holdings, Inc. is recalling 14664 cartons of Western Family Variety Pack Instant Oatmeal cereal bearing the "Best If Used By" Date Code of "DEC0409N" (found on the box top) because a small number of cartons contain an undeclared milk ingredient. People who have an allergy or severe sensitivity to milk ingredients run the risk of a serious or life-threatening allergenic reaction if they consume this product.
Western Family Variety Pack Instant Oatmeal cereal was distributed by Western Family Foods, Inc. to stores in Alaska, California, Colorado, Hawaii, Idaho, Montana, Nevada, Oregon, Utah, Washington, and Wyoming. The product is packaged in cartons weighing 13.8 oz. containing 10 packets of instant oatmeal.
No illnesses have been reported to date, and no other products are affected by this recall.
The company has consulted with the U.S. Food and Drug Administration, and the agency is aware of the company's actions.
The recall was initiated after "fruit and cream" instant oatmeal packets were discovered in Western Family Variety Pack Instant Oatmeal cartons with the best if used by date code of "DEC0409N".
Consumers who have purchased Western Family Variety Pack Instant Oatmeal cereal bearing the "DEC0409N" best if used by date code are urged to return it to the store from which you purchased the product for a full refund. Consumers with questions may call Ralston Foods Consumer Affairs at 1-800-725-7866.
FOR IMMEDIATE RELEASE -- Morristown, NJ, August 1, 2008 -- Actavis Totowa LLC, a generic drug manufacturer, is announcing a voluntary recall, to the retail level, of all drug products manufactured at its Little Falls, New Jersey facility. This is a precautionary, voluntary action by Actavis following an inspection conducted by the Food and Drug Administration earlier this year.
The inspection at Little Falls revealed operations which did not meet the FDA's or Actavis' standards for good manufacturing practices. Actavis Totowa is voluntarily recalling these products from the pharmacy/retail level, which includes wholesalers and hospitals. The company has informed the FDA regarding this action.
This action is not prompted by product complaints or health hazards associated with the products, which are all prescription medications. Patients who may have these medicines in their possession should continue to take them in accordance with their prescriptions, as the risk of suddenly stopping needed medication may place patients at risk. If patients should wish to obtain replacement medications and/or prescription, they should contact their health care professional or pharmacist. For more information regarding this market action, please visit www.actavis.us/RecallFAQ.
Recall letters have been issued to wholesalers and retailers, instructing them to return product to Capital Returns, Milwaukee, WI.
Actavis Totowa, LLC is a United States
subsidiary of Actavis Group hf. This voluntary action is limited only to the
Actavis Totowa products manufactured in the Little Falls, NJ facility listed
below. Products manufactured by Actavis Elizabeth LLC, Actavis South Atlantic
LLC, Actavis Mid Atlantic LLC or Actavis products manufactured in other
facilities are thus not impacted by this recall
| Amantadine 100mg capsules | Meperidine & Promethazine capsules |
| Amibid DM ER tablets | Meperidine HCl 100 mg and 50 mg tablets |
| Amibid DM tablets | Methenamine Mandelate 0.5 g and 1.0 g tablets |
| Amidrine capsules | Mirtazapine 15 mg, 30 mg, and 45 mg tablets |
| Amigesic 500 mg caplets and 750 mg caplets | Mirtazapine OD tablets, 15 mg, 30 mg and 45 mg |
| Amitex PSE tablets | Multi-ret Folic 500 mg tablets |
| Bellamine S tablets | Multi-vita-bets 0.5 mg and 1.0 mg FL & FE tablets |
| Betaxolol 10 mg and 20 mg tablets USP | Multi-vita-bets 0.25 mg, 0.5 mg and 1 mg FL tablets |
| Buspirone HCL 5 mg, 10 mg, 15 mg and 30mg tablets | Naltrexone 50mg tablets |
| Carisoprodol & Aspirin tablets | Oxycodone & Acetaminophen 5/500mg capsules |
| Carisoprodol, Aspirin & Codeine tablets | Oxycodone HCl 5 mg, 15 mg and 30 mg tablets |
| Carisoprodol 350mg tablets | Oxycodone HCl 5 mg capsules |
| Chlordiazepoxide w/ Clidinium Bromide capsules | Pentazocine & Acetaminophen tablets |
| Chlorzoxazone 250mg | Pentazocine & Naloxone tablets |
| Cilostazol tablets 100mg | Phenazopyridine HCl 100 mg and 200 mg tablets |
| Choline Magnesium Trisalicylate 500 mg, 750 mg and 1000 mg tablets | Phendimetrazine Tartrate 35mg tablets |
| Cyclobenzaprine HCL 5 mg and 10 mg | Phentermine HCl 37.5 mg tablets |
| Dexchlorpheniramine Maleate 4 mg and 6 mg tablets | Phentermine HCl 15 mg, 30 mg and 37.5 mg capsules |
| Dipyridamole 25 mg, 50mg, and 75 mg tablets | Prenatal Formula 3 tablets |
| Glyburide 1.5 mg, 3.0 mg and 6.0 mg tablets | Prenatal Plus 27 mg FE tablets |
| Guaifenesin & Codeine Phosphate tablets | Prenatal Rx tablets |
| Guaifenesin & Phenylephrine tablets | Quinaretic 10mg/12.5mg, 20 mg/12.5 mg and 20 mg/25 mg tablets |
| Guanfacine 1.0 mg and 2.0 mg HCl tablets | Rifampin 300mg capsules |
| Hydrocodone & Homatropine tablets | Sodium FL 0.5 mg and 1.0 mg tablets |
| Hydromorphone HCl tablets | Tizanidine HCl 2 mg and 4 mg tablets |
| Hydroxyzine 10 mg, 25 mg and 50 mg tablets | Trimethobenzamide 300mg capsules |
| Hyoscyamine Sulfate 0.125 mg SL | Trimipramine Maleate 25mg, 50mg, 100mg capsules |
| Hyoscyamine Sulfate 0.375mg SR tablets | Trivita 1 mg FL tablets |
| Hyoscyamine Sulfate 0.125 mg (oral) tablets | Ursodiol capsules, 300mg |
| Isradipine 2.5 mg and 5 mg capsules | Vitacon Forte capsules |
| Loxapine 5 mg, 10 mg, 25 mg, and 50 mg capsules | Vitaplex Plus tablets |
| Meclizine Chewable 25 mg tablets | Vitaplex tablets (FC) |
| Meloxicam 7.5 mg and 15 mg tablets | Yohimbine HCl 5.4 mg tablets |
Answers to frequently asked questions regarding this market action can be found on www.actavis.us/RecallFAQ.
FOR IMMEDIATE RELEASE -- July 31, 2008 -- The manufacturer of Wegmans Sorbet is recalling a limited number of 16 oz. Wegmans brand Sorbets because they may contain undeclared milk. People who have an allergy to milk run the risk of a serious or possible life-threatening allergic reaction if they consume the affected products listed below.
The products were distributed throughout Wegmans Food Markets located in New York, Pennsylvania, New Jersey, Virginia, and Maryland.
The sorbets are packaged in 16 oz. paperboard containers and sold in the supermarkets’ ice cream section. All four sorbet flavors: Lemon, Raspberry, Green Apple, and Pink Grapefruit, are affected by this recall. The affected products contain the following "BEST USED BY" date codes on the bottom of the container:
| "BEST USED BY" codes | |
|---|---|
| Green Apple | OCT 2008; MAR 15,09 |
| Lemon | FEB 11,09 |
| Pink Grapefruit | FEB 11,09 |
| Raspberry | SEP 2008; NOV 2,08; FEB 11,09 |
A review of records discovered that product containing milk was packaged in cartons that were not labeled for the presence of milk. Subsequent investigation indicates the cross contamination was caused by a breakdown in the company's production process, which has been corrected.
Consumers who have purchased Wegmans Sorbet with the affected code dates and flavors may return it to Wegmans for a full refund. Consumers with questions may contact the manufacturer at 1-800-873-7797 between the hours of 9:00am -5:00pm Monday thru Friday EST.
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FOR IMMEDIATE RELEASE -- Chicago, Illinois -- July 25, 2008 -- Vita Food Products, Inc. of Chicago, Illinois is notifying the public that twelve individual packages of Vita Nova Salmon, were sold at Kroger stores in Houston, Texas on or after July 22 of this year may be contaminated with Listeria monocytogenes. In addition, 192 individual packages of this same product have either possibly been sold or are being offered for sale at various grocery stores in the Avenol, New Jersey metropolitan area. To date, no confirmed illnesses or complaints have been reported by customers , although the Company is closely monitoring the situation.
The product that is the subject of this public announcement and recall are packages (deep dark blue in color) of smoked salmon that bear the Vita logo in the upper left corner on the part of the packaging that is immediately visible to the consumer. Each package contains 4-10 bacon-style slices (total 3 oz.) of smoked salmon; the slices are contained in a vacuum pack within a box that is 4" wide by 7.5 " in length by 1/2 " in thickness. IMPORTANT: The Code Date of 11/16/08 198 is on the left end flap of each package. This announcement and recall only applies to packages that bear that CODE DATE.
Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea. Listeria infection can cause miscarriages and stillbirths among pregnant women.
If any consumer purchased a product with that CODE DATE from a retail store on or after July 22, 2008 he or she should not consume any of the Vita Nova Salmon product. Then, the Company asks that it be sealed in plastic bag or placed in some similar container and returned to the retailer from which it was purchased. The Company is asking that any person who has purchased the product with this CODE DATE call this telephone number 1-800-989-8482 . If you are experiencing any unusual or severe symptoms such as those described above, go to an emergency room immediately or contact your physician for immediate advice.
At the request of the U.S. Food and Drug Administration, U.S. Marshals seized nearly $74,000 worth of Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI, distributed by SEI Pharmaceuticals, Inc. of Miami, Fla. Although marketed as a dietary supplement to treat erectile dysfunction (ED) and for sexual enhancement, these lots represent an illegally marketed drug containing an undeclared ingredient.
Today's action follows a formal FDA request to SEI Pharmaceuticals (SEI) on May 27, 2008, to recall the lots of Xiadafil VIP tablets. The products were given away at trade shows and sold in eight tablet bottles (Lot # 6K029) and blister cards of two tablets (Lot # 6K029-SEI) bearing an expiration date of September 2009 (09/09). The company, however, refused to recall these products, making the seizure action necessary to prevent additional, illegal Xiadafil VIP products from entering the marketplace.
The FDA's chemical analysis of Xiadafil VIP tablets Lots # 6K029/6K029-SEI found that the product contains hydroxyhomosildenafil, which is chemically similar to sildenafil. Sildenafil is the active ingredient in Viagra, an FDA-approved prescription drug for ED. The FDA has not approved Xiadafil VIP for ED or any other drug use, and the safety and effectiveness of this product is unknown. Although offered for sale as dietary supplements, the seized articles are new drugs that may not be introduced into interstate commerce without an approved new drug application filed with FDA.
"Today's seizure action shows that FDA will take enforcement action to protect the public from dietary supplements that contain prescription drug ingredients that are potentially harmful to consumers," said Margaret O'K Glavin, associate commissioner of the FDA's Office of Regulatory Affairs. "FDA will not tolerate a company's failure to take voluntary action to protect the public health after being given the opportunity by FDA to do so," she added.
On April 22, 2008, the FDA initiated an inspection at SEI Pharmaceuticals following its analysis of the Xiadafil VIP tablets. The company was advised of the FDA's findings and informed of the potential adverse health risks the product posed to unsuspecting consumers. The FDA also warned the company of possible legal actions, including seizure and/or injunction if corrective and preventive actions were not implemented. Although the company committed to halting distribution of the product and deactivated its Internet site, it refused to recall the product already in the market.
On May 13, 2008, Florida state officials issued a "stop sale" action at SEI's distribution facility to keep the illegal product out of the marketplace. This action required SEI to hold, intact, violative Xiadafil VIP tablets found at the facility.
ED is a common problem in men who have diabetes, high blood pressure, high cholesterol, or heart disease. Because they may have been advised against taking ED drugs, men with these conditions may seek alternative products like Xiadafil VIP tablets because they are marketed as "all natural" or as not containing the active ingredients in approved, prescribed ED drugs. Furthermore, because the manufacturing source of the active ingredients in many of these alternative products is unknown, consumers should also be aware that the safety, efficacy, and purity of these ingredients have not been verified by the FDA.
Consumers should discontinue the use of Xiadafil VIP tablets immediately and consult their health care professional if they have experienced adverse events that they believe may be related to the use of this product.
Consumers and health care professionals can report adverse events to the FDA's MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, Md 20852-9787, or online at www.fda.gov/medwatch/report.htm.
FOR IMMEDIATE RELEASE -- June 21, 2008 -- Agricola Zaragoza, Inc. of McAllen, TX is recalling Jalapeno Peppers distributed since June 30th, 2008 because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
The Jalapeno Peppers were distributed to customers in GA and TX.
The Jalapeno Peppers being recalled were shipped in 35lb. plastic crates and in 50lb. bags with no brand name or label.
The recall is a result of sampling by FDA, which revealed that these Jalapeno Peppers were contaminated with the same strain of Salmonella Saintpaul responsible for the current Salmonella outbreak. It is unknown at this time which, if any, of the more than 1,200 illnesses reported to date are related to this particular product or to the grower who supplied this product. Distribution of these products has been suspended while FDA, the Texas Department of State Health Services and the company continue their investigation as to the source of the problem.
Consumers and retailers who purchased Jalapeno Peppers should contact their supplier to determine if their products are involved in the recall. Commercial manufacturers that have used these recalled Jalapeno Peppers as an ingredient in other products (i.e. salsas, etc.) are encouraged to contact their local FDA office to determine if these products should be recalled. Additionally, restaurants, retail food stores, and similar retail institutions that have used these Jalapeno Peppers as a garnish or as an ingredient to prepare entrees, salsas or other products are asked to dispose of these products making sure that all such peppers are not inadvertently made available for purchase, salvage or donation and therefore preventing any possibility for human or animal consumption.. Consumers with questions may contact the company at (956)-631-6405.
FOR IMMEDIATE RELEASE -- June 21, 2008 -- Agricola Zaragoza, Inc. of McAllen, TX is recalling Jalapeno Peppers distributed since June 30th, 2008 because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
The Jalapeno Peppers were distributed to customers in GA and TX.
The Jalapeno Peppers being recalled were shipped in 35lb. plastic crates and in 50lb. bags with no brand name or label.
The recall is a result of sampling by FDA, which revealed that these Jalapeno Peppers were contaminated with the same strain of Salmonella Saintpaul responsible for the current Salmonella outbreak. It is unknown at this time which, if any, of the more than 1,200 illnesses reported to date are related to this particular product or to the grower who supplied this product. Distribution of these products has been suspended while FDA, the Texas Department of State Health Services and the company continue their investigation as to the source of the problem.
Consumers and retailers who purchased Jalapeno Peppers should contact their supplier to determine if their products are involved in the recall. Commercial manufacturers that have used these recalled Jalapeno Peppers as an ingredient in other products (i.e. salsas, etc.) are encouraged to contact their local FDA office to determine if these products should be recalled. Additionally, restaurants, retail food stores, and similar retail institutions that have used these Jalapeno Peppers as a garnish or as an ingredient to prepare entrees, salsas or other products are asked to dispose of these products making sure that all such peppers are not inadvertently made available for purchase, salvage or donation and therefore preventing any possibility for human or animal consumption.. Consumers with questions may contact the company at (956)-631-6405.
FOR IMMEDIATE RELEASE -- July 16, 2008 -- DOMEGA INTERNATIONAL CO., LTD., 98 Bay 35th Street, Brooklyn, NY 11214 is recalling Korica Brand “Mut Gung” Sweetened Ginger because it contains undeclared sulfites. People who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.
The recalled Korica Brand “Mut Gung Sweetened Ginger is sold in uncoded 7 oz plastic tubs and is a product of Vietnam. The product was sold nationwide.
The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspectors and Subsequent analysis of the product by Food Laboratory personnel revealed the presence of sulfites in Korica Brand “Mut Gung” Sweetened Ginger in packages which did not declare sulfites on the label. The consumption of 10 milligrams of sulfites per serving has been reported to elicit severe reactions in some asthmatics. Anaphylactic shock could occur in certain sulfite sensitive individuals upon ingesting 10 milligrams or more of sulfites.
No illnesses involving this product have been reported to date. Consumers who have purchased Korica Brand “Mut Gung Sweetened Ginger should return them to the place of purchase. Consumers with questions may contact the company at 646-938-7345.
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FOR IMMEDIATE RELEASE -- Federal Way, WA -- July 9, 2008 --- Salmolux Inc. of Federal Way, WA, is recalling lot # 01418 of its Wild Alaskan Smoked Salmon Nova Lox sold in 3 ounce packages due to the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
The recalled lot # 01418 of Wild Alaskan Smoked Salmon Nova Lox was distributed in Arizona, California, and Nevada, in Von's retail outlets and to Delaware, Florida, Georgia, Maryland, North Carolina, Pennsylvania, South Carolina, West Virginia, and Virginia in Food Lion retail outlets.
The product comes in a 3 ounce, blue package marked with lot # 01418 on its rear white label bearing the name of the product, its ingredients, and an expiration date.
No illnesses have been reported to date in connection with this problem.
After routine testing by the Florida Department of Agriculture and Consumer Services, Listeria monocytogenes was found in 3 ounce packages of Wild Alaskan Smoked Salmon Nova Lox.
Consumers who have purchased the recalled 3 ounce packages bearing the lot # 01418 of the salmon are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at (253) 874-2026 x214.
This recall is being conducted with the knowledge of the Food and Drug Administration.
FOR IMMEDIATE RELEASE -- Pompano Beach, FL – July 01, 2008 – Jack Distribution, LLC, 1501 Green Road Unit C Pompano Beach, Florida 33064 and its wholesale distributors G & N works, Inc., and Devine Distribution, Inc., announced today that they are conducting a voluntary nationwide recall of the following lot numbers of the company's supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. (Rize 2 lot numbers CG-84 expires 11/10, GD-98 expires 08/10, CC-06 expires 06/10, 709 expires 09/10, CG-79 expires 11/10) (Rose 4 Her lot number CG-78 expires 11/10).
Jack Distribution, LLC, is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of Rize 2 and Rose 4 Her samples from lots manufactured and packaged in 2007 found the product contains potentially harmful, undeclared ingredients. FDA asserts that its chemical analysis revealed that these lots of Rize 2 The Occasion and Rose 4 Her contain thiomethisosildenafil, an analog of sildenafil, the active ingredient of a FDA-approved drug used for Erectile Dysfunction (ED). FDA maintains that this ingredient is close in structure to sildenafil and is expected to possess a similar pharmacological and adverse event profile. This undeclared chemical poses a potential threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
Consumers with diabetes, high blood
pressure, high cholesterol, or heart disease often take nitrates. ED is a common
problem in men with these conditions, and consumers may seek these types of
products to enhance sexual performance.
Customers who have this product in their possession should stop using it
immediately and contact their physician if they have experienced any problems
that may be related to taking this product.
Any adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.
The company advises that any unused portions from these lot numbers be returned to the place of purchase for a full refund of purchase price. G & N Works and Devine Distribution are not shipping any Rize 2 or Rose 4 Her that is in stock while additional samples are being tested, they expect to begin shipping again in 2-4 weeks.
Rize 2 and Rose 4 Her are sold in adult stores, vitamin & nutrition shops, convenience stores, and via the internet nationwide. The Rize 2 product is sold as a (single blister pack, three count bottles, twelve count bottles, and thirty count bottles. Rose 4 Her is only available in single blister packs and three count bottles.
The Company is taking this voluntary action because it is committed and is always concerned with the health of persons who have consumed this product. The Company is reviewing the procedures and policies of all firms involved with the manufacture of the product to ensure that there will be no future issues with regard to Rize 2 and Rose 4 Her pills composition. The Company is working closely with the FDA in the recall process and is committed to the quality and integrity of its products. It sincerely regrets any inconvenience to consumers and its other customers.
FOR IMMEDIATE RELEASE -- CARY, IL -- June 27, 2008 -- As a precautionary measure, Sage Products announced a voluntary recall of limited lots of 2% Chlorhexidine Gluconate (CHG) Cloth Patient Preoperative Skin Preparation product. Testing of bulk 2% CHG solution from an outside supplier was found positive for Burkholderia cepacia (B. cepacia).
B. cepacia poses little
medical risk to healthy people. However, people who have certain health problems
such as weakened immune systems or chronic lung diseases, particularly cystic
fibrosis (CF), may be more susceptible to infections with B. cepacia. B
cepacia is a known cause of infections in hospitalized patients. The
effects of B. cepacia on people vary widely, ranging from no symptoms
at all, to serious respiratory infections, especially in patients with CF. The
intended application of the 2% CHG Cloth product is topical, for the skin only,
and it is not for oral or internal use.
The recall includes the following products:
|
Product Code Number |
Lot Number | Product Code Number | Lot Number |
|---|---|---|---|
|
9705 |
10722 |
9707 |
10672 |
|
9705 |
10729 |
9707 |
10753 |
|
9706 |
10718 |
9707 |
10755 |
|
9707 |
10357 |
9707 |
10944 |
|
9707 |
10365 |
|
|
|
9707 |
10641 |
|
|
Product was distributed to U.S. hospitals and medical centers nationwide. Affected product was shipped between 4/28/08 and 6/19/08. This voluntary recall is being conducted with the knowledge of the Food and Drug Administration. Sage Products has received no reports of patient injury. No other products from Sage are included in this recall.
Customers who have these products should stop usage, sale and distribution, and should contact Sage Products to coordinate product return and replacement. Additional information is posted at www.sageproducts.com/recall.
Sage Products Customer Service hotline: 1-800-421-6556.
Bay Valley Foods Issues Allergy Alert on Undeclared Milk in Mislabeled Kroger Chicken Noodle Soup
FOR IMMEDIATE RELEASE -- Westchester, IL -- June 24, 2008 -- Bay Valley Foods is recalling five cases (24 cans per case) of mislabeled Kroger Chicken Noodle Soup because it may contain undeclared milk. The cans actually contain Cream of Celery soup. People who have an allergy or severe sensitivity to milk are at risk if they consume these products. No illnesses have been reported to date in connection with this alert.
The recalled soup may have been distributed by Kroger to Dillon stores in Kansas, Missouri and Nebraska.
The recalled product, Kroger Chicken Noodle Soup, comes in 10.5 ounce cans and is marked with lot code 52104098, and a "best before" date code of 40910 (April 9, 2010) that can be found on the bottom of the can. Consumers are urged to return the product to the store where it was purchased for a full refund.
Consumers with questions may contact Bay Valley Foods Consumer Response Department at 1-800-983-0823.
Today, at the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago.
U.S. Marshals seized all FDA-regulated animal food susceptible to rodent and pest contamination. The seized products violate the Federal Food, Drug, and Cosmetic Act because it was alleged in a case filed by the United States Attorney that they were being held under unsanitary conditions. (The Act uses the term "insanitary" to describe such conditions).
During an FDA inspection of a PETCO distribution center in April, widespread and active rodent and bird infestation was found. The FDA inspected the facility again in May and found continuing and widespread infestation.
"We simply will not allow a company to store foods under filthy and unsanitary conditions that occur as a direct result of the company's failure to adequately control and prevent pests in its facility," said Margaret O'K. Glavin, associate commissioner for regulatory affairs. "Consumers expect that such safeguards will be in place not only for human food, but for pet food as well."
The distribution center in Joliet, Ill., provides pet food products and supplies to PETCO retail stores in 16 states including Alabama, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Missouri, Nebraska, Ohio, Oklahoma, Tennessee, Texas, and Wisconsin.
FDA has no reports of pet illness or death associated with consumption of animal food distributed by PETCO, and does not have evidence that the food is unsafe for animals. However, the seized products were in permeable packages and held under conditions that could affect the food's integrity and quality.
As a precaution, consumers who have handled products originating from the PETCO distribution center should thoroughly wash their hands with hot water and soap. Any surfaces that came in contact with the packages should be washed as well. Consumers are further advised as a precaution to thoroughly wash products sold in cans and glass containers from PETCO in the 16 affected states.
If a pet has become ill after eating these food products, pet owners should contact their veterinarian and report illnesses to FDA state consumer complaint coordinators.
FOR IMMEDIATE RELEASE -- Carson, CA -- June 6, 2008 -- Leiner Health Products Inc. ("Leiner" or "the Company") today announced that it is recalling its 32 ounce plastic bottles of Liquimax Complete Nutrition Multivitamin Formula, labeled with UPC Code 7497052290, 7497023607, or 7497023696 because the product may contain undeclared fish (not shellfish), tree nuts (almonds, pecans and/or walnuts), and wheat. People who have allergies to fish, tree nuts and/or wheat run the risk of serious or life-threatening allergic reaction if they consume these products.
The recalled Liquimax Multivitamin was distributed nationwide in retail stores.
The Company has been made aware of the presence of these allergens after receiving consumer reports of an allergic reaction. The Company is aggressively investigating the situation, and currently believes a certain number of bottles of the product contain the listed allergens. Further, the Company has consulted with the U.S. Food and Drug Administration (the "FDA") and the agency is aware of the Company's actions.
Consumers allergic to the above listed allergens are advised not to consume the product and are asked to call 1-800-533-8482 for a full refund. This number can be contacted 24 hours a day with representatives available Monday through Friday between the hours of 8 am and 5 pm (EDT).
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
| Online: www.fda.gov/medwatch/report/hcp.htm | |
| Regular Mail: use postage-paid FDA
form 3500 available at:
www.fda.gov/MedWatch/getforms.htm. Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787 | |
| Fax: 1-800-FDA-0178 |
The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these raw, red tomatoes.
FDA recommends that consumers not eat raw red Roma, raw red plum, raw red round tomatoes, or products that contain these types of raw red tomatoes unless the tomatoes are from the sources listed below. If unsure of where tomatoes are grown or harvested, consumers are encouraged to contact the store where the tomato purchase was made. Consumers should continue to eat cherry tomatoes, grape tomatoes, and tomatoes sold with the vine still attached, or tomatoes grown at home.
On June 5, using traceback and other distribution pattern information, FDA published a list of states, territories, and countries where tomatoes are grown and harvested which have not been associated with this outbreak. This updated list includes: Arkansas, California, Georgia, Hawaii, North Carolina, South Carolina, Tennessee, Texas, Belgium, Canada, Dominican Republic, Guatemala, Israel, Netherlands, and Puerto Rico. The list is available at www.fda.gov/oc/opacom/hottopics/tomatoes.html#retailers. This list will be updated as more information becomes available.
FDA’s recommendation does not apply to the following tomatoes from any source: cherry, grape, and tomatoes sold with the vine still attached.
FDA recommends that retailers, restaurateurs, and food service operators not offer for sale and service raw red Roma, raw red plum, and raw red round tomatoes unless they are from the sources listed above. Cherry tomatoes, grape tomatoes, and tomatoes sold with the vine still attached, may continue to be offered from any source.
Since mid April, there have been 145 reported cases of salmonellosis caused by Salmonella Saintpaul nationwide, including at least 23 hospitalizations. States reporting illnesses linked to the outbreak include: Arizona, California, Colorado, Connecticut, Idaho, Illinois, Indiana, Kansas, New Mexico, Oklahoma, Oregon, Texas, Utah, Virginia, Washington, and Wisconsin. Salmonella Saintpaul is an uncommon type of Salmonella.
Salmonella can cause serious and sometimes fatal infections particularly in young children, frail or elderly people, and those with weakened immune systems. Healthy persons often experience fever, diarrhea (which may be bloody), nausea, vomiting, and abdominal pain. In rare circumstances, the organism can get into the bloodstream and produce more severe illnesses. Consumers who have recently eaten raw tomatoes or foods containing raw tomatoes and are experiencing any of these symptoms should contact their health care provider. All Salmonella infections should be reported to state or local health authorities.
FDA recognizes that the source of the contaminated tomatoes may be limited to a single grower or packer or tomatoes from a specific geographic area. FDA also recognizes that there are many tomato crops across the country and in foreign countries that will be ready for harvest or will become ready in the coming months. In order to ensure that consumers can continue to enjoy tomatoes that are safe to eat, FDA is working diligently with the states, the Centers for Disease Control and Prevention, the Indian Health Service, and various food industry trade associations to quickly determine the source of the tomatoes associated with the outbreak.
FDA is taking these actions while the agency continues to investigate this outbreak with state and federal partners. Such actions are a key component of FDA’s Food Protection Plan, a scientific and risk-based approach to strengthen and protect the nation’s food supply.
FDA will continue to issue updates as more specific information becomes available.
FOR IMMEDIATE RELEASE -- May 28, 2008 – Orval Kent Foods is voluntarily recalling approximately 23,000 pounds of Amish Macaroni Salad that may pose a health risk.
This voluntary action is being taken in response to the results of a test conducted on a single package of Amish Macaroni Salad by the Ohio Department of Agriculture and Consumer Services, Division of Food Safety, for E. coli O157:H7.
It is important to note that no illnesses associated with consumption of this product have been reported.
The only product included in this recall is Amish Macaroni Salad with the following UPC codes and associated Use By dates:
| UPC 7945368281 Orval Kent Amish Macaroni Salad, 5 pound container, Use By 6/12/08 | |
| UPC 7347468281 Yoder’s Amish Macaroni Salad, 1 pound container, Use By 6/7/08 | |
| UPC 7347401045 Yoder’s Amish Macaroni Salad, 2 pound container, Use by 6/7/08 | |
| UPC 7347488729 Yoder’s Amish Macaroni Salad, 5 pound container, Use By 6/7/08 |
This specific product was shipped to customers who have distribution to retail and food service establishments in the following areas: Delaware, Illinois, Indiana, Maryland, Michigan, New Jersey, New York, Ohio, and Pennsylvania.
E. coli O157:H7 causes a diarrheal illness often with bloody stools. Although most healthy adults can recover completely with a week, some people can develop a form of kidney failure that can lead to serious kidney damage and even death. Young children, the elderly and those with weak immune systems are most susceptible to foodborne illnesses.
No other Yoder’s or Orval Kent deli salads, or other code dates or UPC’s of the Amish Macaroni Salad are included in this recall.
Our highest priority is protecting the health and safety of our customers, consumers and their families. Today’s precautionary action is a measure to ensure this priority is carried out, and that we maintain the loyalty and trust of our consumers.
Consumers are urged to return all un-opened containers to their place of purchase for a full refund.
Consumers with any questions may contact Orval Kent at 1-800-544-1246.
FOR IMMEDIATE RELEASE -- Bradford, MA - May 29, 2008 - International Pharmaceuticals, Ltd., P.O. Box 5165, Bradford, MA 01835, announced today that it is conducting a voluntary recall of all the company’s supplement product sold under the brand name of Viril-Ity-Power (VIP) Tabs, 560mg/serving.
International Pharmaceuticals, Ltd. is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of a sample from one lot of the product revealed that it contained a potentially harmful undeclared ingredient, hydroxyhomosildenafil. FDA asserts that this ingredient is an analog of sildenafil. Sildenafil is the active chemical ingredient of an FDA-approved drug used for Erectile Dysfunction (ED) in men to enhance sexual performance. The use of undeclared chemicals pose a threat to consumers because they may harmfully interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take such nitrates.
VIP Tabs are sold in retail outlets nationwide and are packaged into 2-capsule blister packs and 8-capsule bottles.
Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.
The Company advises that any unused portions be returned to CB Distributors in Benoit, Wisconsin, in accordance with return instructions/questions obtained by calling (800)-273-4137, Ext. 3.
Any adverse events that may be related to the use of this product should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or online at www.fda.gov/medwatch/report.htm.
The Company is working closely with the FDA in the recall process and is taking this voluntary action because it is committed to the quality and integrity of it’s products, and is always concerned with the health of persons who may have consumed this product.
The Company sincerely regrets any inconvenience to consumers, and is reviewing the procedures and policies of all firms involved with the manufacture of this product to ensure that there will be no subsequent issues with regard to the composition of this product in the future.
Medicis Announces Voluntary Recall of Solodyn® (minocycline HCL, USP) 90 Mg Tablets, Extended Release; Lot Numbers B080037 and B080038 Due to Product Mix-Up
SCOTTSDALE, Ariz. -- May 16, 2008 -- Medicis today announced that the Company is voluntarily recalling lot numbers B080037 (Exp: 12/09) and B080038 (Exp: 12/09) of the antibiotic SOLODYN® (minocycline HCl, USP) Extended Release Tablets, 90 mg, 30-count bottles (NDC 99207-461-30). Medicis has received a report that one bottle in lot number B080037 contains AZASAN® (azathioprine tablets) 75 mg (NDC 65649-231-51) instead of SOLODYN® (minocycline HCl, USP) Extended Release Tablets, 90 mg. AZASAN® is an immuno-suppressive agent used in transplant patients to prevent kidney rejection and for the treatment of rheumatoid arthritis. Taking AZASAN® instead of SOLODYN® presents a health hazard and safety risk to patients. Side effects associated with the use of AZASAN®, particularly in the elderly, include mylosuppression (decrease in the number of red and white blood cells and platelets), infection, bleeding, chills, nausea, vomiting and diarrhea. Joint and muscle pain are also common side effects. Unanticipated interactions with other drugs may also lead to serious adverse events. SOLODYN® is manufactured by AAIPharma, Inc. under contract to Medicis. The two lots were manufactured during February 2008. The recall is limited to these lots, and ample supplies of SOLODYN® remain on the market.
Any inquiries related to this recall should be addressed to Stericycle Customer Service at 1-888-656-6381 with representatives available Monday through Friday, 8 a.m. to 11 p.m. EST. For any medical information inquiries or to report an adverse event related to this recall, contact Medicis at 1-800-900-6389 with representatives available 24 hours a day, 7 days a week.
Health care professionals may continue to prescribe the Medicis brand SOLODYN®.
This recall is being conducted in cooperation with the contract manufacturer of the products and with the knowledge of the FDA.
Any adverse reactions experienced with the use of this product, and/or quality problems, also may be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at
www.fda.gov/medwatch.SOLODYN is a registered trademark of Medicis Pharmaceutical Corporation. AZASAN is a registered trademark of AAIPharma, Inc.
The U.S. Food and Drug Administration today directed Hope Food Supply Inc., a Pasadena, Texas, food processing company, to shut down and immediately recall all products manufactured from its Texas facility since 2007.
The company, under a different name, had manufactured dried smoked catfish steaks and other smoked seafood products and had been subject to a consent decree of permanent injunction requiring it to develop and implement an adequate Hazard Analysis and Critical Control Point (HACCP) plan for its fish and fishery products. The firm had not developed this plan. The company cannot restart manufacturing until they have implemented an FDA-approved HACCP plan.
"We simply will not allow a company to put the public's health at risk by not implementing adequate procedures and plans to produce safe food," said Margaret O'K. Glavin, associate commissioner for regulatory affairs. "The FDA will take action against companies and against their executives who violate the law and endanger public health."
The FDA's HACCP regulations require that all seafood processors develop and implement adequate HACCP plans that identify all food safety hazards that are likely to occur for each kind of seafood product that they process, and set forth preventative measures to control those hazards.
The HACCP violations documented by the FDA pose a public health hazard because, without adequate controls, Hope Food Supply's seafood products could harbor pathogenic bacteria such as Staphylococcus aureus and Listeria monocytogenes. Food products with these kinds of pathogens can cause serious illnesses in people who eat them.
The company's products have been distributed nationwide. The FDA is advising consumers who bought smoked seafood products to check with the place of purchase to determine if the products came from Hope Foods. If so, consumers should throw the products out by placing them in a trash receptacle.
Consumers who have been eating Hope Seafood Supply's dried smoked catfish or other smoked seafood products and have experienced adverse reactions should consult their health care professional. Consumers and health care professionals can also report adverse events to the FDA consumer complaint coordinator in their geographic area. Contact numbers may be found online at www.fda.gov/opacom/backgrounders/complain.html.
For more information, consumers can call the FDA's toll-free Food Safety Hotline at 1-888-SAFEFOOD.
FOR IMMEDIATE RELEASE -- Morristown, NJ -- April 25, 2008 -- Actavis Totowa LLC, a United States manufacturing division of the international generic pharmaceutical company Actavis Group, is initiating a Class I nationwide recall of Digitek® (digoxin tablets, USP, all strengths) for oral use. The products are distributed by Mylan Pharmaceuticals Inc., under a "Bertek" label and by UDL Laboratories, Inc. under a "UDL" label.
The voluntary all lot recall is due to the possibility that tablets with double the appropriate thickness may have been commercially released. These tablets may contain twice the approved level of active ingredient than it appropriate.
Digitek® is used to treat heart failure and abnormal heart rhythms. The existence of double strength tablets poses a risk of digitalis toxicity in patients with renal failure. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Death can also result from excessive Digitalis intake. Several reports of illnesses and injuries have been received.
Actavis manufactures the products for Mylan and the products are distributed by Mylan and UDL under the Bertek and UDL labels. Bertek and UDL are affiliates of Mylan.
Any customer inquiries related to this action should be addressed to Stericycle customer service at 1-888-276-6166 with representatives available Monday through Friday, 8 am to 5 pm EST. Additional information about the voluntary recall can also be found at www.actavis.us.
Retailers who have this product are urged to return the product to their place of purchase. If consumers have medical questions, they should contact their health care providers.
This recall is being conducted with the knowledge of the Food and Drug Administration.
Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
FOR IMMEDIATE RELEASE --Mount Crawford, Virginia -- April 23, 2008 --- WhiteWave Foods Company is voluntarily recalling 11-ounce plastic single serve bottles of Silk Soymilk Chocolate Flavor because it may contain undeclared milk protein. The individual bottles are printed with both a "use by" date of May 7, 2008 (printed as 05 07 08) and a Universal Product Code (UPC) of 2529360028. Consumers can find this information on the back of the individual bottle.
People who have an allergy or severe sensitivity to milk protein run the risk of a health problem or illness if they consume this product. Some reactions have been reported.
This affected product was distributed nationwide and reached consumers through retail and foodservice outlets. WhiteWave's sales team is working with distributors to actively recover any affected product remaining on store shelves.
HOW TO IDENTIFY THE RECALLED PRODUCT
This recall includes only 11-ounce single serve plastic bottles of Silk Soymilk
Chocolate Flavor with both a "use by" date of May 7, 2008 (printed as 05 07 08)
and a UPC code of 2529360028. Consumers should look for this information on the
back of the bottle.
The Company apologizes for any inconvenience to its customers. Consumers who purchased the product may return it to the place of purchase for a full refund or exchange. Consumers with questions can contact the Company at 1-800-587-2259.
The Food and Drug Administration has been notified of this recall.
Pulmuone Wildwood, Inc. Issues Allergy Alert on Undeclared Eggs in Leek and Oriental Noodle Fried Dumplings
FOR IMMEDIATE RELEASE -- April 16, 2008 -- Pulmuone Wildwood, Inc. of Fullerton, CA is recalling 1,000 cases of Leek and Oriental Noodle Fried Dumplings, because they may contain undeclared eggs. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume these products.
The product labeled as Leek and Oriental Noodle Fried Dumpling contains egg which was listed as "Albumen" in the ingredient statement but was not declared on the allergen statement.
Leek and Oriental Noodle Fried Dumplings was distributed in California, Illinois, Texas and Georgia through retail stores.
The product affected is packaged in a white resealable 25.4 oz pouch with the UPC code 801114-306338 and the Code dates 2/2/2009, 2/9/2009 and 3/6/2009.
No illnesses have been reported to date.
The labeling issue was reported to Pulmuone Wildwood, Inc. upon receipt of the product. Investigation indicates that the problem was cause by a breach in communication with the supplier regarding product formulation and packaging information. This labeling error was limited in scope and no other food products were involved.
The Company has been in phone and email contact with 100% of the distributors and stores which received this product.
Consumers who have purchased Leek and Oriental Noodle Fried Dumplings or have questions are urged to contact Annie Chon @ 714.578.1487 or
anniec@pmo.com
Grand Carnival L.L.C Issues Allergy Alert on Undeclared Milk in its "S’morestick Kit"
FOR IMMEDIATE RELEASE -- April 16, 2008 -- Grand Carnival L.L.C. of Fenton, MO, is voluntarily recalling "S'morestick Kits" because chocolate pieces contained within the S'morestick Kit contain milk which is not declared on the product's ingredient statement. People who have an allergy or severe sensitivity to milk run the risk of a potentially serious or life-threatening allergic reaction if they consume chocolate products containing milk.
The recalled "S'morestick Kits" were in limited distribution to Garden Ridge retail stores located in TX, KY, MO, TN, OK, NC, FL, SC, GA, IL, OH, VA, AR, MI, and IN, and bear the "Use By" date of "2/14/09".
The "S'morestick Kit" is packaged in a clear plastic tube containing individual clear plastic packages of marshmallows, graham crackers, and chocolate pieces. S'morestick Kits subject to this recall do NOT have a "contains milk" statement following the ingredient statement affixed to the clear plastic tube. There is no health risk for consumers who are not allergic to milk.
There is one reported allergic reaction attributed to this product.
The recall was initiated after it was discovered that early shipments of S'morestick Kits were distributed in packaging that did not reveal the presence of milk. The Company is in the process of revising its labeling to declare milk as an ingredient in the product.
Concerned consumers who have purchased a S'morestick Kit lacking the "contains milk" statement on the product's label are urged to contact Grand Carnival L.L.C. at 877-305-3382 for a full refund.
Private Selection Ice Cream Recalled From Kroger Stores In Twelve Southeastern States
FOR IMMEDIATE RELEASE -- CINCINNATI, Ohio, April 7, 2008 – Inter-American Products, Inc., a division of The Kroger Co., today announced a recall on two codes of Private Selection Light Churned Mint Chocolate Chip Ice Cream in 1.75-quart containers with a "Sell By" date of December 3, 2008.
The two codes are: DEC0308 8070 and DEC0308 8080.
The ice cream is being recalled because it may contain egg, soy, and wheat, which are not listed in the ingredient statement. People who have an allergy to eggs run the risk of serious or life-threatening reaction if they consume this product.
The ice cream was distributed to Kroger stores in Alabama, Arkansas, Georgia, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Nebraska, South Carolina, Tennessee, and Texas.
No other Private Selection Ice Cream products are affected by this recall.
Customers are encouraged to return the product to their Kroger store for a full refund.
No illnesses have been reported. For most consumers, there is no safety issue with the ice cream. Consumers with questions or concerns may call Inter-American Products, Inc. at 1-800-697-2448.
FOR IMMEDIATE RELEASE -- Minneapolis, MN -- April 5, 2008 -- Malt-O-Meal announced today that it is voluntarily recalling its unsweetened Puffed Rice and unsweetened Puffed Wheat Cereals produced with "Best If Used By" codes between April 8, 2008 (coded as "APR0808") and March 18, 2009 (coded as "MAR1809") because they may have the potential to be contaminated with Salmonella.
The recalled product was distributed nationally, marketed under the Malt-O-Meal brand and as some private label brands including Acme, America's Choice, Food Club, Giant, Hannaford, Jewel, Laura Lynn, Pathmark, Shaw's, ShopRite, Tops and Weis Quality. A comprehensive listing of impacted products can be found at www.malt-o-meal.com/recallinfo.
No illnesses have been reported to date in connection with this situation. All other Malt-O-Meal products are unaffected by this action and are safe for continued sale and consumption. The products affected by this recall represent less than one-half of one percent of the company's annual production of ready-to-eat cereal.
"Our first and highest priority is the safety of the consumers who use our products," said Malt-O-Meal President and CEO Chris Neugent. "It's important that we spread the word about this situation quickly and broadly in order to remove even the slightest possibility that someone will consume something harmful. We apologize for this situation and promise to do everything to complete the recall as quickly as possible."
The recall was initiated after the company's internal routine food safety testing detected the presence of Salmonella in a product produced on March 24, 2008. The company immediately commenced an investigation to determine the root cause of this one positive finding as well as the extent of any possible exposure. Initial results from this follow-up investigation indicate that additional product may have been exposed to this contaminant. Thus, out of an abundance of caution to protect consumers, the company has chosen to voluntarily remove all unsweetened Puffed Rice and unsweetened Puffed Wheat products with "Best If Used By" codes between April 8, 2008 (coded as "APR0808") and March 18, 2009 (coded as "MAR1809"). Investigation into the source of the Salmonella has determined a root cause of this situation and corrective measures have been taken to ensure that there is no reoccurrence of this issue.
Persons infected with Salmonella may experience a variety of symptoms and illnesses. According to the U.S. Food and Drug Administration, persons infected with Salmonella may experience fever, diarrhea, nausea, vomiting, and abdominal pain. In rare circumstances, infection with Salmonella can result in more severe illnesses, some potentially life threatening.
Consumers who have purchased any products covered by this recall are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-877-665-9331. Information regarding this recall, including images of the Malt-O-Meal product packaging, also will be posted to the company's website at www.malt-o-meal.com/recallinfo.
FOR IMMEDIATE RELEASE -- Salinas, California – April 3, 2008 --- Taylor Fresh Foods, of Salinas, California is voluntarily recalling selected fresh cut fruit products which may contain cantaloupe from the Honduran grower Agropecuaria Montelibano identified by FDA to have the potential to be contaminated with Salmonella, Taylor Fresh Foods had previously begun to recover this product on March 22, based on a notice published by the U.S. FDA.
The products being recalled include cut cantaloupe and mix cut fruit in bowls and trays of all sizes distributed by Taylor Fresh Foods. Retail and convenience store products involved were removed from sale prior to Monday, March 24. Foodservice distributors, who sell their own brand, have been notified.
Labels include the following: Taylor Farms Gourmet Fruit Tray featuring Creamy Yogurt Dip, Taylor Fresh Melon Mix, Taylor Fresh Fruit Mix, Fresh Fruit Tray with Creamy Strawberry Dip, with Best if Used By Dates before March 30, 2008. Any dates after this are not affected.
Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
We are unaware to date of any illnesses that may be associated with any products containing cantaloupe, sold by Taylor Fresh Foods, or its distributors.
Consumers and customers who have this product should not consume this product and dispose of this product. Consumers with questions may contact Taylor Fresh Foods at (831) 754-0471.
FOR IMMEDIATE RELEASE -- Westchester, Ill.-- March 31, 2008 -- Bay Valley Foods is recalling 535 cases of "America's Choice® Classic Caesar Dressing" because some of the bottles produced in February 2008 have an incorrect ingredient label on the back of the bottle. The incorrect label on the back includes ingredient and nutrition information for Chunky Blue Cheese Dressing and does not declare the presence of fish, soy and wheat. Consumers who have allergies to fish, soy and wheat run the risk of a serious or life threating allergic reaction if they consume the mislabeled product.
No illnesses have been reported to date in connection with this alert, and there is no risk to consumers who are not allergic to fish, soy and wheat.
The recalled bottles of "America's Choice Classic Caesar Dressing" were distributed through Great Atlantic & Pacific Tea Company (A&P) stores including A&P, Super Fresh, Food Basics USA, and Waldbaum's in Connecticut, New Jersey, Pennsylvania, Delaware, New York, and the District of Columbia.
The recalled product, "America's Choice Classic Caesar Dressing" comes in a 16 ounce plastic bottle and is marked with a "best before" date code of 02-09-09 that can be found on the back label. If the ingredient label on the back is for "Chunky Blue Cheese Dressing," consumers may return the product to the store where it was purchased for a full refund.
Consumers with questions may contact Bay Valley Foods Consumer Response Department at 1-800-983-0823.
FOR IMMEDIATE RELEASE -- Lawrence, Massachusetts -- March 28, 2008 -- JARD Marketing, Lawrence, Massachusetts is recalling selected fresh cut fruit products which contain cantaloupe which has the potential to be contaminated with Salmonella. On March 26, 2008, JARD marketing was requested by its supplier T. M. Kovacevich International Inc, to recall products produced with cantaloupe from Agropecuaria Montelibano. Foodservice products are packed in plastic pails or jars, and retail products are packed in plastic cups and trays. This recall affects all packs and sizes. Products under this recall were distributed in Maine, New Hampshire, Vermont, Massachusetts, Connecticut, Rhode Island, New York, New Jersey and Pennsylvania.
Food Service products containing cantaloupe packed in plastic pails and jars include the following brands: Pebble Beach, Festival Of Fruit, Cornucopia Sweet, Jambo Chef, Fowler Fruit Mix, Instantwhip, Syracuse Banana and City Line Food Dist. Pails under this recall are coded with an expiration date from "Exp Apr 7, 2008" to "Exp Apr 22, 2008 or with a Julian Code of "08067" to "08082". Plastic jars under this recall are coded with an expiration date of "Exp Apr 22, 2008" to "May 7, 2008" or with a Julian Code of "08067" to "08082".
Retail products containing cantaloupe packed in plastic cups and trays include the following brands: Frosty Fresh, Fresh Hand Cut, Fruit On The Go, Highland Park, Bruegger’s Bagels, Sid Wainer & Son, Hannaford Brothers and Garden Highway Plant # P-005. Plastic cups and trays under this recall are coded with a sell by date of "3/29/08" or earlier.
Symptoms of food borne Salmonella infection include nausea, vomiting, fever, diarrhea, and abdominal cramps. In persons with poor health or weakened immune systems, Salmonella can invade the bloodstream and cause life-threatening infections.
We are unaware to date of any illnesses that may be associated with any products containing cantaloupe, sold by JARD Marketing Corp., or its distributors.
Establishments who have any of the products involved should contact their supplier for disposition instructions. Consumers with questions may contact JARD Marketing Corp. at (978) 681-8900.
FOR IMMEDIATE RELEASE -- Londonderry, NH -- March 28, 2008 -- Organic yogurt maker Stonyfield Farm is voluntarily recalling Stonyfield Organic Fat Free Blueberry Yogurt, packaged in 6 oz cups, carrying product codes printed along the cup bottom that start with the following dates:
Apr 13 08
Apr 14 08
Apr 15 08
April 25 08
Apr 26 08
The recall comes in response to consumer complaints reporting plastic or glass fragments in these particular batches of fat free blueberry yogurt. There have been no reports of injury. People who bite into or swallow a fragment could possibly be injured, prompting this precautionary recall. Although the company believes the problem is not widespread, we are taking this measure to ensure the safety of our consumers.
Stonyfield Farm is advising our distribution network to immediately remove these specific code-dates of 6-ounce fat free blueberry yogurt from retail shelves. The yogurts are sold at natural food stores and grocery retailers nationwide.
Consumers who may have purchased fat free blueberry yogurts with these code dates are asked to return opened and unopened containers to their retailers. You will be reimbursed for the full value of your purchase.
Consumers with questions should contact Stonyfield Farm Consumer Relations at 1-800-PRO-COWS or email us at crelations@Stonyfield.com.
"Our first priority has always been and always will be the welfare of our consumers," says Gary Hirshberg, Stonyfield Farm President and CE-Yo. "While we continue to investigate these complaints and believe that the risk of injury is extremely remote, we feel that this voluntary measure is the prudent and responsible step at this time."
FOR IMMEDIATE RELEASE --Pompano Beach, FL -- March 24, 2008 --- Central American Produce, Inc. of Pompano Beach, FL announces a voluntary recall of cantaloupes grown, packed and shipped by an independent third-party grower, Agropecuaria Montelibano of San Lorenzo Valle, Honduras. The product was distributed nationwide and Canada. Based on current information, the cantaloupe grown, packed and shipped from Agropecuaria Montelibano appears to be associated with a Salmonella Litchfield outbreak in the United States and Canada.
In persons with poor health or weakened immune systems, Salmonella can invade the bloodstream and cause life-threatening infections. Symptoms of food-borne Salmonella infection include nausea, vomiting, fever, diarrhea, and abdominal cramps. Individuals who have recently eaten cantaloupe and experienced any of these symptoms should contact their health care professional.
The FDA advises that U.S. grocers, food service operators and produce processors remove from their stock any cantaloupes grown packed and shipped from this company. The FDA is also advises consumers who have recently bought cantaloupes to check with the place of purchase to determine if the fruit came from this specific grower and packer. If so, consumers should throw away the cantaloupes. The cantaloupes were distributed for sale in medium brown cardboard cartons with the brands “Mikes Melons” or “Mayan Pride” all showing “PRODUCE OF HONDURAS” printed on each of the four side panels of the carton. The address of the shipper appears on one end panel of the carton as follows:
GROWN, PACKED AND SHIPPED BY:
AGROPECUARIA MONTELIBANO
SAN LORENZO, VALLE, HONDURAS
There are other firms that are involved in this recall using other labels of the same grower, including Mikes Melons. The FDA is taking this preventive measure while the agency continues to investigate this outbreak in cooperation with the Centers for Disease Control and Prevention and state partners.
For more information on produce safety, please visit: http://www.cfsan.fda.gov/~dms/prodsafe.html.
Consumers with additional questions should contact Central American Produce, Inc. at 954-943-2303.
Acme Issues Voluntary Recall for Acme Labeled Cinnamon
Rolls with Icing
Recall affecting all Acme locations in New
Jersey, Pennsylvania, Delaware and Maryland
FOR IMMEDIATE RELEASE -- Malvern, PA -- March 18, 2008 -- Acme Markets is issuing a voluntary recall on all codes of Acme label 4-pack cinnamon rolls with icing due to the undeclared milk ingredient. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product. The recall affects all Acme locations in New Jersey, Pennsylvania, Delaware and Maryland.
"Acme is committed to the safety of its customers and routinely inspects product labels for accuracy and compliance," said Taryn Duckett, manager of communications and public affairs. "The product is being removed from the shelf and customers who have purchased the product may bring it back to an Acme store location for a full refund or exchange."
Customers who have health-related concerns should contact their physician.
Williams Foods, Inc. Issues Allergy Alert on Undeclared Milk in Bass Pro Shops Uncle Buck's Light 'N Krispy Fish Batter Mixes
FOR IMMEDIATE RELEASE -- Lenexa, KS -- March 18, 2008 -- Williams Foods Inc, of Lenexa KS., is voluntarily recalling 22 ounce canisters of Bass Pro Shops Uncle Buck's Light 'n Krispy Original and Light 'n Krispy Hot & Spicy Fish Batter Mixes and 8 ounce pouches of Bass Pro Shops Uncle Buck's Light 'n Krispy Original Fish Batter Mix because the products contain undeclared milk (as part of a minor component of added natural flavors). People who have an allergy or severe sensitivity to milk run the risk of serious allergic reaction if they consume these products.
The product was distributed through Bass Pro Shops retail stores in the United States.
The product is sold in Bass Pro Shops Uncle Buck's labeled 22 ounce canisters and 8 ounce flexible pouches. This recall applies to the following lot numbers: 31207A11, 35107A11, 06308A11 (22 ounce canisters) and 3530716 (8 ounce pouches). Only the "Light 'n Krispy" version of the Bass Pro Shop's Uncle Buck's Fish Batter Mixes are affected by this recall.
There have been no reported allergic reactions attributed to this product. The problem was discovered by Williams Foods during a routine label review.
Williams Foods confirmed in its investigation that the products were produced with an ingredient that contains milk that is not declared on the label.
Concerned consumers who have packages of 22 ounce canisters of Bass Pro Shops Uncle Buck's Light 'n Krispy Original and Light 'n Krispy Hot & Spicy Fish Batter Mixes and 8 ounce pouches of Bass Pro Shops Uncle Buck's Light 'N Krispy Original Fish Batter Mix should return them to the stores where they were purchased for a full refund. Any consumers with questions about this recall should also contact Williams Foods Corporate Quality Department at 1-800-255-6736.
Food For Life Baking Co., Inc. Recalls Spelt Bread
FOR IMMEDIATE RELEASE -- Corona, CA -- March 18, 2008 -- Food For Life Baking Company of Corona, California is voluntarily recalling 2,241 cases of Spelt Bread (UPC# 07347200168) because they contain spelt grain which is known to be a hybrid of wheat. People who have allergies to wheat or those with Celiac Disease may run the risk of a serious or life threatening allergic reaction if they consume spelt products.
The recalled products were sold nationwide through health food distributors and natural food retailers.
Food For Life Spelt Bread is sold frozen in a 24 oz. (680g) light blue package and bears either of the two following descriptions
Affected lot numbers are: H1847, H2042, H2136, H2435, H2872, H2974, H3224, H3460, I0485.
No illnesses have been reported to date in connection with this problem.
The recall was initiated as a precautionary measure following an FDA investigation concluding that the product contained undeclared wheat.
This recall is being made with the knowledge and in cooperation with the Food and Drug Administration.
Consumers who have purchased any of these products are urged to return them unopened to the place of purchase for a refund.
Consumers with questions may contact us toll free at: (800) 797-5090
Slade Gorton & Co. Recalls "Icybay Cooked Langostinos" Because of Possible Health Risk
FOR IMMEDIATE RELEASE -- Boston, MA -- March 14, 2008 -- Slade Gorton & Co is issuing a voluntary recall of its "ICYBAY" cooked, ready to eat, frozen Langostinos because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Although healthy individuals may suffer only short-term symptoms such as fever, headache, stiffness, nausea, abdominal pain and diarrhea, Listeria monocytogenes infection can cause miscarriages and stillbirths among pregnant women.
The product retails in one pound, clear plastic package marked with UPC 0-73129-61672-8 on the top and with an expiration date of June 2009 and is distributed under the brand name of "ICYBAY". The product also was distributed to wholesale accounts, also under the "ICYBAY" brand, in five pound clear plastic packages containing either 70-90 count, 90-125 count or 120-150 count. This recall involves production dates of July 18, 2007 through August 13, 2007 and/or Julian dates of 199 through 232.
The recalled "ICYBAY" cooked langostinos were distributed to retailers in Massachusetts and Maryland, over the course of the past several weeks. The majority of the retail distribution was removed from shelves immediately upon notice of the potential of contamination. The recalled "ICYBAY" cooked langostinos were distributed to wholesalers in Colorado, Connecticut, Indiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nebraska, New Jersey, New York, North Carolina, Pennsylvania, Ohio, Oklahoma, Texas, Vermont, West Virginia and Wisconsin.
The potential for contamination was noted after a Canadian government laboratory, CFIA, found that one sample was believed to be contaminated with Listeria monocytogenes.
No illnesses have been reported to date in connection with this product.
President Kim Gorton said her company, one of the largest private seafood distributors in the United States, strictly follows HACCP procedures and FDA guidelines for testing its seafood products to ensure their wholesomeness and safety.
She said that "while the report from Canada only involves a small sample of the langostinos, we are issuing this voluntary recall, as a precautionary measure, out of concern for the health and safety of the consuming public."
Distribution of the product has been suspended while FDA and the company continue to confirm testing and investigate the source of any potential problem. Slade Gorton & Co. will use an independent testing service to determine the accuracy of the Canadian findings.
Consumers who have purchased one pound packages of "ICYBAY" cooked langostinos are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-800-225-1573.
FOR IMMEDIATE RELEASE -- March 7, 2008 -- The Texas Department of State Health Services (DSHS) has closed Aransas, Corpus Christi and Copano bays to shellfish harvesting and has issued a recall of oysters, clams and mussels because of an algae bloom.
DSHS officials say high concentrations of the Dinophysis organism have been found in several locations in the area. The toxin produced by this algae bloom, okadaic acid, can accumulate in shellfish tissue and cause diarrhetic shellfish poisoning, or DSP, in people who consume oysters, clams or mussels. Cooking does not destroy the toxin.
Shellfish harvested from these bays on March 1 or later are included in the recall. Consumers who purchased shellfish March 1 or later are advised not to eat them. People should either call the store where the shellfish were purchased to determine the date and location of harvest or dispose of them. The toxin does not affect other seafood.
DSHS officials say that preliminary test results indicate that levels of okadaic acid in oyster samples taken from the bays exceed federal guidelines. Final test results will be available next week. DSHS will monitor and determine when it is safe to reopen the shellfish areas.
DSP symptoms include vomiting, diarrhea, nausea and cramping. Symptoms, which usually last two to three days, can begin from 30 minutes to 12 hours after eating shellfish containing the toxin. DSP usually is not life threatening and does not generally cause long-term effects. DSHS is not aware of any illnesses associated with this algae bloom.
Dinophysis occurs naturally in ocean waters and estuaries and is not related to pollution. Typically it is not found in high numbers along the Texas Gulf Coast. High concentrations can turn the water an orange or brown color. DSHS officials say they know of no health issues associated with people being in water containing the algae.
Limited Number of Aunt Jemima Pancake & Waffle Mix Products Recalled for Possible Health Risk
– The Quaker Oats Co. announced the products in the recall are a small quantity of Aunt Jemima Pancake & Waffle Mix: Original, Original Complete and Buttermilk Complete, which may have potential salmonella contamination. No other Aunt Jemima, frozen Aunt Jemima or Quaker products are affected.
The products, sold in 2 pound and 5 pound boxes with Best Before dates of FEB 08 09 H through FEB 16 09 H stamped on the top, contain the following UPC codes:
Salmonella is a food borne illness that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain.
No illnesses have been reported in connection with this issue to date. There is very low risk of illness when preparation directions on box are followed and product is not consumed raw or undercooked. Salmonella bacteria is killed at a temperature of 160° F.
If consumers have this product with the indicated UPC codes and Best Before dates, they should return it to the place of purchase for a full refund. Consumers with questions may contact the company by calling the toll-free hotline at 1-800-407-2247 or by logging onto www.auntjemima.com.
Quaker is in the process of recovering the product involved. Quaker knows specifically to which customer warehouses the product was shipped. Approximately 98% of the product is within Quaker's control. The 2% of product which is outside of Quaker's control was shipped to a limited number of retail and mass merchandiser stores (no direct distribution to West Coast). Of that small quantity, the vast majority likely has not been placed on store shelves. Product was shipped to 17 states including Texas, Georgia, Alabama, South Carolina, North Carolina, Illinois, Florida, Missouri, Minnesota, Colorado, Wisconsin, Ohio, New York, New Mexico, Kansas and Utah.
Gorton's Seafood Recalls 6 Crispy Battered Fish Fillets Due to Possible Adulteration
Contact:
FOR IMMEDIATE RELEASE -- GLOUCESTER, Mass., February 29, 2008 -- Gorton's Seafood, based in Gloucester, Mass., is voluntarily recalling one frozen seafood product with a specific date code because the product may have been adulterated with pills. While there has been only one isolated case of adulteration and no reports of illness from the product, the company is taking this action as a precautionary measure.
The following product is subject to recall:
The product included in this recall was produced on October 16, 2007 and distributed to retail outlets in Alabama, California, Delaware, Florida, Georgia, Mississippi, Oklahoma, Pennsylvania, South Carolina, Tennessee and Texas. The product is being removed from retail outlets, and consumers are urged to look in their freezers for products bearing this particular code.
Gorton's is conducting an investigation into the source of the problem and working with the Pennsylvania Department of Agriculture and the Food & Drug Administration. There have been no reported illnesses from consumers.
Consumers who have the product may return it to Gorton's for a refund by calling 800-896-9479
Actavis Recalls Remaining Fentanyl Patches in the US as Precaution
FOR IMMEDIATE RELEASE -- Morristown, NJ, March 1, 2008 -- Actavis Inc., the United States manufacturing and marketing division of the international generic pharmaceutical company Actavis Group hf, today announced that its subsidiary Actavis South Atlantic LLC is proceeding with the voluntarily recall from wholesalers and pharmacies of all lots of Fentanyl transdermal system CII patches sold in the United States.
This recall is an expansion of the Company's initial recall of fourteen lots of Fentanyl transdermal patches announced on February 17, 2008. That recall was due to the identification of a possible fold-over defect present in the product that potentially could cause leakage of the fentanyl gel. The remaining lots of Fentanyl transdermal system patches are being recalled as a precautionary measure because Actavis lacks assurance that all patches are free from defects.
All of the recalled patches were manufactured by Corium International Inc., a contract manufacturer for Actavis, and sold nationwide in the United States.
Fentanyl patches sold by Actavis in Europe are not affected by this recall.
As per the approved product labelling for Fentanyl transdermal system, fentanyl is a potent Schedule II opioid medication. Fentanyl patches that are leaking or damaged in any way should not be used. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal. Anyone who comes in contact with fentanyl gel should thoroughly rinse exposed skin with large amounts of water only; do not use soap. Immediately dispose of affected patches that may be damaged or compromised in any way by flushing them down the toilet, using caution not to handle them directly. Damaged and/or compromised patches that have leaked gel will not provide effective pain relief.
Please note: Actavis South Atlantic LLC was formerly known as Abrika Pharmaceuticals Inc. The pouches containing the patches may be labelled with an Abrika Pharmaceuticals label, but the outer carton bears the Actavis logo with the following product names:
Actavis Fentanyl Transdermal System, 25 mcg/hr.
NDC 67767-120-18.
Actavis Fentanyl Transdermal System, 50 mcg/hr. NDC 67767-121-18.
Actavis Fentanyl Transdermal System, 75 mcg/hr. NDC 67767-122-18.
Actavis Fentanyl Transdermal System, 100 mcg/hr. NDC 67767-123-18.
The lots covered by this recall have expiration dates between May 2009 and December 2009. Anyone who has fentanyl patches labelled with an Abrika or Actavis label should check them for these expiration dates.
Anyone with Actavis Fentanyl transdermal system patches with the lot numbers listed on the schedule, should call 1 877 422 7452.
Patients using fentanyl patches who have medical questions should contact their health-care providers.
This recall is being conducted with the
knowledge of the Food and Drug Administration.
Any adverse reactions experienced with the use of this product, and/or quality
problems should also be reported to the FDA's MedWatch Program by phone at
1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers
Lane, Rockville, MD 20852-9787, or on the MedWatch website at
www.fda.gov/medwatch.
Fentanyl transdermal system is indicated for the management of persistent, moderate to severe chronic pain that requires continuous, around the clock opioid administration for an extended period of time and cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate release opioids.
Schedule
|
Lot |
Exp. Date |
NDC |
Strength |
|
27540 |
Aug 09 |
67767-120-18 |
25mcg/hr |
|
27584 |
Aug 09 |
67767-120-18 |
25mcg/hr |
|
27666 |
Sep 09 |
67767-120-18 |
25mcg/hr |
|
27759 |
Oct 09 |
67767-120-18 |
25mcg/hr |
|
27611 |
Oct 09 |
67767-120-18 |
25mcg/hr |
|
27762 |
Oct 09 |
67767-120-18 |
25mcg/hr |
|
27761 |
Oct 09 |
67767-120-18 |
25mcg/hr |
|
27832 |
Nov 09 |
67767-120-18 |
25mcg/hr |
|
27747 |
Nov 09 |
67767-120-18 |
25mcg/hr |
|
27758 |
Nov 09 |
67767-120-18 |
25mcg/hr |
|
27903 |
Dec 09 |
67767-120-18 |
25mcg/hr |
|
27573 |
Sep 09 |
67767-121-18 |
50mcg/hr |
|
27576 |
Sep 09 |
67767-121-18 |
50mcg/hr |
|
27667 |
Oct 09 |
67767-121-18 |
50mcg/hr |
|
27668 |
Oct 09 |
67767-121-18 |
50mcg/hr |
|
27581 |
Oct 09 |
67767-121-18 |
50mcg/hr |
|
27763 |
Oct 09 |
67767-121-18 |
50mcg/hr |
|
27751 |
Nov 09 |
67767-121-18 |
50mcg/hr |
|
27586 |
Aug 09 |
67767-122-18 |
75mcg/hr |
|
27572 |
Sep 09 |
67767-122-18 |
75mcg/hr |
|
27582 |
Oct 09 |
67767-122-18 |
75mcg/hr |
|
27583 |
Oct 09 |
67767-122-18 |
75mcg/hr |
|
27745 |
Oct 09 |
67767-122-18 |
75mcg/hr |
|
27746 |
Oct 09 |
67767-122-18 |
75mcg/hr |
|
27539 |
Aug 09 |
67767-123-18 |
100mcg/hr |
|
27574 |
Sep 09 |
67767-123-18 |
100mcg/hr |
|
27575 |
Sep 09 |
67767-123-18 |
100mcg/hr |
|
27577 |
Sep 09 |
67767-123-18 |
100mcg/hr |
|
27578 |
Oct 09 |
67767-123-18 |
100mcg/hr |
|
27579 |
Oct 09 |
67767-123-18 |
100mcg/hr |
|
27580 |
Oct 09 |
67767-123-18 |
100mcg/hr |
|
27610 |
Oct 09 |
67767-123-18 |
100mcg/hr |
|
27612 |
Oct 09 |
67767-123-18 |
100mcg/hr |
|
27743 |
Oct 09 |
67767-123-18 |
100mcg/hr |
Palo Alto Labs Issues a Voluntary Nationwide Recall of Aspire36 and Aspire Lite, two Products Marketed as Dietary Supplements
FOR IMMEDIATE RELEASE -- Port St. Lucie, FL -- February 28, 2008- Palo Alto Labs, 265 SW Port St. Lucie Blvd., Suite 252, Port St. Lucie, FL 34984, announced today that it is conducting a voluntary nationwide recall of the company's supplement products sold under the name Aspire36 and Aspire Lite. Palo Alto Labs is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of Aspire36 and Aspire Lite samples found that the products contained Aildenafil in trace amounts and Dimethyl sildenafil thione (sulfoaildenafil) a purported analog of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). Sulfoaildenafil is close in structure to Sildenafil and is expected to possess a similar pharmacological and adverse event profile. This may pose a threat to consumers because the analogue may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.
Aspire36 and Aspire Lite are sold nationwide. The products are sold as a blister pack containing one liquid capsule or a bottle containing either three (3) or twelve (12) liquid capsules.
Consumers who have Aspire36 and Aspire Lite in their possession should stop using them immediately. In the event of any adverse side effects due to the consumption of these products, consumers should contact a physician right away. Any adverse events that may be related to the use of these products should be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.
The Company is advising consumers to return any unused Aspire36 and Aspire Lite, for a refund of the full purchase price, to the retail location from which it was purchased or to the Company directly if it was purchased from the Company as a part of its Direct Response Program. Consumers can call 1-(877)240-3340 for instructions on the return and refund process.
Palo Alto Labs conducts stringent quality control testing on both raw materials and finished products. Previous testing protocols did not include a test for the presence of Aildenafil or sulfoaildenafil but Palo Alto Labs assures consumers that this deficiency has been rectified. Palo Alto Labs apologizes for any inconvenience and expresses its concern for the health of consumers by conducting a voluntary recall action. Palo Alto Labs promises to ensure quality and integrity of all its products and the company is working closely with the FDA in the recall process.
#
Baxter to Proceed with Recall of Remaining Heparin Sodium Vial Products
FOR IMMEDIATE RELEASE -- DEERFIELD, Ill., February 28, 2008 – Baxter International Inc. announced today that the company is proceeding with the voluntary recall of all remaining lots and doses of its heparin sodium injection multi-dose, single-dose vials and HEP-LOCK heparin flush products.
The company initially recalled nine lots of heparin sodium injection multi-dose vials on January 17, 2008 as a precautionary measure due to a higher than usual number of reports of adverse patient reactions involving the product and suspended production earlier this month.
Given the widespread use of this blood thinner and the impact a product shortage would have on operating rooms, dialysis centers and other critical care areas, the FDA and Baxter concluded that removing additional lots and doses of Baxter's heparin from the market earlier would have created more risk to patients requiring heparin therapy than the increased potential for experiencing an adverse reaction. Accordingly, the FDA and Baxter decided not to recall all Baxter heparin vial products at that time. The FDA has now concluded that there is sufficient capacity on the part of other suppliers that Baxter's recall will not jeopardize access to this drug, and has told Baxter that the company can now proceed with recalling its remaining heparin sodium injection and heparin flush products.
Although the vast majority of the reports of adverse reactions have been associated with the multi-dose products, Baxter is taking the precautionary step of recalling all remaining heparin sodium injection and heparin flush products that are currently on the market. In addition to the previously recalled lots of heparin sodium injection 1000 units/mL 10mL and 30mL multi-dose vials, Baxter's recall will now include the remaining lots of those products and heparin sodium injection 5000 units/mL 10mL multi-dose vials, heparin sodium injection 10,000 units/mL 4mL multi-dose vials, heparin sodium injection 1000 USP units/mL, 5000 USP units/mL, and 10,000 USP units/mL single-dose vials, and all HEP-LOCK and HEP-LOCK U/P, 10 USP units/mL and 100 USP units/mL vials, both preserved and preservative-free.
This recall does not involve Baxter's heparin pre-mix IV solutions in bags: heparin sodium in 5% dextrose injection and heparin sodium in 0.9% sodium chloride injection.
"We have assurance from the U.S. Food and Drug Administration that there is an adequate supply in the market to meet the demand for these critical and lifesaving drugs," said Peter J. Arduini, president of Baxter's Medication Delivery business. "The safety and quality of our products is always our highest priority, and we will continue to collaborate with the FDA as we work to determine the cause of the increased rate of adverse reactions and resolve this issue."
Nearly all reported adverse reactions have occurred in three specific areas of product use – renal dialysis, invasive cardiovascular procedures and apheresis procedures. Reported adverse patient reactions have included: stomach pain or discomfort, nausea, vomiting, diarrhea, decreased or low blood pressure, chest pain, fast heart rate, dizziness, fainting, unresponsiveness, shortness of breath, the feeling of a strong or rapid heartbeat, drug ineffectiveness, burning sensation, redness or paleness of skin, abnormal sensation of the skin, mouth or lips, flushing, increased sweating, decreased skin sensitivity, headache, feeling unwell, restlessness, watery eyes, throat swelling, thirst, bleeding tendencies and difficulty opening the mouth. Some of these reactions, particularly profound and refractory hypotension, may be severe or life-threatening.
Customers have been instructed to discontinue use and segregate the recalled product from the rest of their inventory. Customers should then contact Baxter to arrange for return and replacement product. Customers with recalled product purchased indirectly should contact their wholesaler or distributor for return and replacement product. Customers with questions may contact the Center for One Baxter at 1-800-4-BAXTER (1-800-422-9837). Representatives will be available twenty-four hours a day, seven days a week.
Walker's Food Products Company Recalls Four Bean Salad Because Of Possible Health Risk
FOR IMMEDIATE RELEASE -- February 28, 2008 --- Walker's Food Products Company of North Kansas City, Missouri, is recalling its 16oz., 5-lb. and 10-lb. containers of Four Bean Salad because of potential contamination with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product, even if it does not look or smell spoiled. Botulism, a potentially fatal form of food poisoning, can cause the following symptoms: general weakness, dizziness, double vision, and trouble with speaking or swallowing. Difficulty in breathing, weakness of muscles, abdominal distension, and constipation may also be common symptoms. People experiencing these problems should seek immediate medical attention.
The recalled Four Bean Salad was distributed to distributors in Missouri, Kansas, Nebraska, and Iowa for ultimate distribution to retail stores and restaurants. The product in the 16 oz. containers was packaged under the Kay's Gourmet brand name. The product in the 5-lb. and 10-lb. containers was packaged under the Walker's Food Products Co. brand name. The containers are round clear plastic packages, which have an expiration date stamped on the bottom surface. The expiration dates subject to recall are 12/23/07 thru 04/5/08.
No illnesses have been reported to date in connection with this problem.
Walker's Food Products became aware of the problem after being notified by another company they had received beans that had been recalled due to being potentially contaminated with Clostridium botulinum. The manufacturer of the beans and FDA are continuing to investigate the source of this problem.
Wang Globalnet Issues Allergy Alert on Undeclared Eggs, Peanuts and Milk Allergens in Lotte Margaret Brand Korean Cracker
- Wang Globalnet of 365 Ten Eyck Street, Brooklyn, NY 11206, is recalling 19 gram packages of Lotte Margaret Brand Korean Cracker because they may contain undeclared eggs, peanuts and milk allergens. Consumers who are allergic to eggs, peanuts and milk may run the risk of serious or life-threatening allergic reactions if they consume this product.
The product comes in a 19 gram cardboard box marked with item#: 00438 on the top and a code date of 08.08.06.B2 stamped on the side. The recalled packages of Lotte Margaret Brand Korean Cracker were distributed nationwide in retail stores.
The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of undeclared eggs in the 19 gram packages of Lotte Margaret Brand Korean Cracker which did not declare eggs on the label. Furthermore, manufacturer’s formulation revealed that sliced peanuts and milk powder were used as ingredients in the 19 gram packages of Lotte Margaret Brand Korean Cracker which did not declare milk or peanuts on the label.
No illnesses or allergic reactions involving this product have been reported to date.
Consumers who have purchased 19 gram packages of Lotte Margaret Brand Korean Cracker are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 718-821-5252.
FOR IMMEDIATE RELEASE -- Jersey City, NJ -- February 1, 2008 -- Summit Import Corp. is recalling "Oriental Mascot Brand Sweetened Sliced Coconut" because it contains undeclared sulfites. Consumers who have severe sensitivity to sulfites may run the risk of serious or life-threatening allergic reactions if they consume this product.
The product comes in an uncoded 4 oz plastic container. The recalled "Oriental Mascot Brand Sweetened Sliced Coconut" was distributed in New York State. It is a product of China.
The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis of the product by Food Laboratory personnel revealed the presence of undeclared sulfites in "Oriental Mascot Brand Sweetened Sliced Coconut" in packages which did not declare sulfites on the label. The consumption of 10 milligrams of sulfites per serving has been reported to elicit severe reactions in some asthmatics. Anaphylactic shock could occur in certain sulfite sensitive individuals upon ingesting 10 milligrams or more of sulfites. Analysis of the "Oriental Mascot Brand Sweetened Sliced Coconut" revealed they contained 70 mg per serving.
No illnesses involving this product have been reported to date. Consumers who have purchased "Oriental Mascot Brand Sweetened Sliced Coconut" are urged to return it to the place of purchase for full refund. Consumers with questions may contact the company at 201-839-2882 Attention: Mr. Lee.
FOR IMMEDIATE RELEASE -- February 9, 2008 -- Choyce Products of Honolulu, Hawaii is voluntarily recalling 5,452 pounds of frozen Yellowfin Tuna because it has the potential to be contaminated with Salmonella.
Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illness such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
The frozen Yellowfin tuna was distributed on Oahu and most likely reached consumers in the form of a mixed, previously frozen, seafood product through its customers. Choyce Products received the tuna from a mainland importer who confirmed the tuna was sent from Indonesia.
Choyce Products' customers received the cubed tuna in frozen form. The frozen product is packaged in labeled white cardboard shipping boxes containing 22 pounds of product. These boxes each contain 11 2-pound packages of vacuum-packed product in unlabeled plastic bags. White stickers on the cardboard shipping boxes have the following code information:
| Lot Number 0727408005899 with Production Dates October 1 and 2, 2007 | |
| Lot Number 0725008005899 with Production Date September 7, 2007 | |
| Lot Number 0726408005899 with Production Date September 21, 2007 |
Choyce Products unknowingly sold the tuna to its customers before learning of the possible contamination. The FDA and the state of Hawaii are conducting a joint investigation of a variety of vendors due to the state receiving Salmonella illness reports between October 1, 2007 and December 31, 2007. The source has not yet been identified. Choyce Products will destroy all returned and inventoried recalled product.
Consumers can call 808-839-1502 if they have concerns or questions about tuna-containing products they have consumed. Those Choyce Products customer who suspect they may have this product should keep it in their possession and call 808-839-1502 with the label information. Should the tuna be from the parcel in question, it will be retrieved and destroyed by Choyce Products and a refund will be issued.
FOR IMMEDIATE RELEASE -- Chattanooga, TN -- February 8, 2008 -- Chattem, Inc. announced today that it is initiating a voluntary Nationwide recall of its Icy Hot Heat Therapy products, including consumer "samples" that were included on a limited promotional basis in cartons of its 3 oz. Aspercreme® product. This recall is being conducted to the consumer level.
Chattem is recalling these products because it has received some consumer reports of first, second and third degree burns as well as skin irritation resulting from consumer use or possible misuse of these products.
All lots and all sizes of the following Icy Hot Heat Therapy products are affected by this recall:
NOTE: if products have been removed from their holding cartons the recalled products are packaged in a red colored plastic pouch which states Icy Hot Heat Therapy and either Back or Arm/Neck and Leg.
Single consumer use "samples" of Icy Hot Heat Therapy- Arm, Neck and Leg were included on a limited promotional basis in yellow and red cartons of 3 oz. Aspercreme Pain Relieving Crème. The samples were distinct and stand-alone products, clearly labeled as "Icy Hot Heat Therapy Air Activated Heat," with their own internal labeling.
These products are sold over the counter through food, drug and mass merchandisers.
Consumers who have the Icy Hot Heat Therapy products under recall should immediately stop using the products, discard them, and/or return them to Chattem, Inc.
Product may be returned for a full refund (average retail price) by calling Chattem’s Consumer Affairs Department at 1-888-458-3487 (M-F from 8am to 4pm EST) or via our website at www.Chattem.com.
Any adverse reactions experienced with the use of the Icy Hot Heat Therapy products should also be reported the FDA Adverse Event Reporting Program, either online at www.fda.gov/medwatch/report.htm, or by fax at 800-FDA-0178, and to Chattem at the above toll-free number.Chattem is notifying its customers, including distributors and retailers, about this recall, and is arranging for immediate return of all recalled products to Chattem.
This recall only involves the above listed Icy Hot Heat Therapy products including single consumer use "samples" that were included in cartons of 3 oz. Aspercreme Pain Relieving Crème and does not involve any other Icy Hot or Aspercreme products.
Chattem is committed to the integrity and safety of its products and is undertaking this voluntary recall with the full knowledge of the Food and Drug Administration.
Consumers with questions or concerns about this product may contact Chattem’s Consumer Affairs Department at 1-888-442-4464 (M-F 8am to 4pm EST)
.
Breaking News: could February 8th be the day the Clinton Obama ticket becomes reality
Today, February 6th we were supposed to be covering another event but were told that people like us should never had been invited to begin with. We weren't certain if it meant us as in internet news or us meaning senior citizens or us as in the fact since it was military day and I was wearing my navy cap.
To get to the chase. We were killing time and went to get something to eat. We sat down next to a gentleman that picked up his cell phone, the words "Obama kicked Hillarie's ass on Tuesday," drew our attention. This was followed by blab blab blab, "I want a meeting set up for Friday to talk about the Clinton Obama ticket." Talk from aides on the phone to him followed by "Bill has got to do what is ethically right," more aides talking, "then I want this meeting to happen this Friday and if he doesn't go along then he is out, you understand that don't you!"
More aides talking then, "I will be available the next 24 hours and get back to me on my cell phone and make it happen!"
He then gets up and leaves.
Clinton acknowledged Wednesday that she loaned her campaign $5 million late last month as Obama was outraising and outspending her heading into Feb. 5 Super Tuesday contests.
An example as to why never conduct a private conversation in a restaurant on a cell phone and that because the Democratic party powers may be demanding a Clinton Obama ticket to stop McCain it does not mean either party is ready to make it happen right now but it is inevitable to get party support.
Consumer Warning: Contaminated Cheese
FOR IMMEDIATE RELEASE --Indianapolis, IN -- January 30, 2008 -- Routine surveillance by the Indiana State Board of Animal Health's Dairy Division revealed high levels of staphylococcus aureus (or "staph") in several raw milk cheeses manufactured by Grassy Meadows dairy of Howe, Ind. Because of the facility's location, consumers in Ohio and Michigan, as well as Indiana, should also check their refrigerators for these items.
Products of concern include, but are not limited to, Colby (lot no. 210317 and 19177), Jalapeno natural cheese (lot no. 2617, 21017 and 11017), "Homemade" cheese (lot no. 19267 and 19227), Monterey Jack (lot no. 18207 and 2937), and garlic pepper cheese (lot no. 19147). All are sold in wedges or blocks of various weights.
Due to the nature of the manufacturing process for raw milk cheese, BOAH advises consumers not to eat any cheese from this facility purchased prior to January 30, 2008. According to Terry Philibeck, Director of BOAH Dairy Divison, the agency has not yet been able to identify when the staph contamination began. Cheese purchased prior to January may be contaminated.
Grassy Meadows products were sold directly to consumers from the dairy farm, located in LaGrange County, Ind., as well as more than a dozen retail health food stores in Northeastern/Fort Wayne Indiana region. BOAH is working to secure a complete list of retails outlets that carry this product.
All the samples taken indicated higher-than-allowed levels of staph. No consumer illness or complaints have been reported.
Staph infections can cause nausea, vomiting, abdominal cramping, headache and muscle cramping. The greatest health risk is to the very young, the very old and those with compromised immune systems.
The State Board of Animal Health is cooperating with the Indiana State Department of Health to update county health departments statewide as retail outlets are identified.
Consumers should not consume these products, but return them to their place of purchase.
FOR IMMEDIATE RELEASE -- DEERFIELD, Ill., January 25, 2008 – Baxter Healthcare Corporation has announced the voluntary recall of nine lots of heparin sodium injection 1000 units/mL 10mL and 30mL multi-dose vials. The company began recalling the lots on January 17, 2008 as a precautionary measure due to an increase in the number of reports of adverse patient reactions that may be associated with the product. Baxter is conducting a thorough investigation of these reports to identify the cause of the increase in allergic-type reactions.
Adverse patient reactions have included: stomach pain or discomfort, nausea, vomiting, diarrhea, decreased or low blood pressure, chest pain, fast heart rate, dizziness, fainting, unresponsiveness, shortness of breath, feeling your heart beat strong or fast, drug ineffectiveness, burning sensation, redness or paleness of skin, abnormal sensation of the skin, mouth or lips, flushing, increased sweating, decreased skin sensitivity, headache, feeling unwell, restlessness, watery eyes, throat swelling, thirst and difficulty opening the mouth. Some of these reactions may be severe or life threatening.
Heparin is a prescription, injectable blood anticoagulant (also called a blood thinner). The 1,000 units/mL multi-dose vials are primarily used for hemodialysis and cardiac invasive procedures. To date, the company has not observed a significant increase in adverse event reports occurring with any other of its heparin presentations.
Customers have been instructed to discontinue use and segregate the recalled product from the rest of their inventory. Customers should then contact Baxter to arrange for return and replacement product. Customers with recalled product purchased indirectly should contact their wholesaler or distributor for return and replacement product. Customers with questions may contact Baxter at 1-800-667-0959. Representatives are available Monday through Friday from 7 a.m. to 6 p.m. CT.
Baxter International Inc. through its subsidiaries, assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives. For more information about Baxter, visit www.baxter.com
FOR IMMEDIATE RELEASE -- January 18, 2008 -- AM2 PAT, Inc., Angier, North Carolina, is initiating a Nationwide recall of all lots of both Heparin and Saline pre-filled flushes manufactured by AM2 PAT. These products are distributed under two brand names, Sierra Pre-Filled Inc. and B. Braun. These products are sold in 3ml, 5ml sizes for Heparin and 3ml, 5ml and 10ml sizes for Normal Saline. Both products are sold as pre-filled syringes.
One lot under recall of this product 1003-02, Lot 070926H, heparin IV flush syringes has been found to be contaminated with Serratia marcescens, which has resulted in patient infections. CDC has confirmed growth of Serratia marcescens from several unopened syringes of this product.
This type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries and/or death.
Consumers and user facilities who have any of these recalled pre-filled syringes, Heparin or Saline Lock Flush Solution USP, should stop using the product immediately. These products should be immediately quarantined in your inventory and returned to your distributor immediately.
The following information for this recall includes:
MANUFACTURER: Sierra Pre-Filled, Inc., Angier, North Carolina
PRODUCT DESCRIPTION: Heparin Lock Flush Solution USP, All Strengths and Sizes
Saline Lock Flush Solution USP, All Strengths and Sizes
| LOT # | NDC # | CATALOG # | Product Brand Name |
| All | 64054-1003-02 | 1003-02 | Heparin Lock Flush 100units/ml 5ml |
| 64054-1003-01 | 1003-01 | Heparin Lock Flush 100units/ml 3ml | |
| 64054-3005-02 | 3005-02 | Heparin Lock Flush 10units/ml 5ml | |
| 64054-3003-02 | 3003-02 | Heparin Lock Flush 10units/ml 3ml | |
| 64054-3003-06 | 3003-06 | Heparin Lock Flush 10units/mL 3ml (6ml syringe) | |
| 64054-3005-06 | 3005-06 | Heparin Lock Flush 10units/mL 5ml (6ml syringe) | |
| 64054-0910-2 | 0910-12 | Normal Saline Flush 10ml | |
| 64054-0905-2 | 0905-12 | Normal Saline Flush 5ml | |
| 64054-0903-2 | 0903-12 | Normal Saline Flush 3ml |
The firm voluntarily recalled these products after confirming bacterial contamination in some end user samples of product code 1003-02, Lot 070926H.
These products have been distributed nationwide.
It appears from an ongoing Food and Drug Administration (FDA) inspection of AM2 PAT, Inc.’s facility that the firm is not in compliance with the Quality System regulation and failed to have adequate controls to ensure necessary sterility of its pre-filled syringes.
Consumers with questions may contact Sierra Pre-Filled at 919-552-9689, Monday through Friday, 10am-5pm Eastern Standard Time.
This recall is being conducted with the knowledge of the Food and Drug Administration.
Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
FOR IMMEDIATE RELEASE -- January 18, 2008 -- B. Braun Medical Inc. was recently notified by its contract manufacturer, AM2PAT Inc., of a nationwide recall of all lots and sizes of Pre-filled Heparin and Saline Flush Syringes.
|
Catalog #
|
Lot #
|
Description
|
|---|---|---|
| 513584 | All | Normal Saline 3mL in 12 mL Syringe |
| 513586 | All | Normal Saline 5mL in 12 mL Syringe |
| 513587 | All | Normal Saline 10mL in 12 mL Syringe |
| 513610 | All | 10 units/mL Heparin, 5mL in 12 mL Syringe |
| 513611 | All | 100 units/mL Heparin, 3mL in 12 mL Syringe |
| 513612 | All | 100 units/mL Heparin, 5mL in 12 mL Syringe |
Customers that have the recalled product in their possession should discontinue use immediately. If patients report any problems that may be related to usage of this product a physician should be contacted. Customers may contact the B. Braun Medical Inc. Customer Support Department at (800) 227-2862, Monday through Friday, 8 AM to 7 PM EST for instructions for handling the affected product and to arrange for replacement product.
Based on ongoing FDA inspection of AM2PAT Inc.'s facility, and CDC investigation it has been determined that there is a potential for the sterility of these affected products to be compromised, which may result in potential contamination. AM2PAT previously initiated a recall of one lot of Sierra Pre-Filled Heparin (lot #070926H) that was found to be contaminated with Serratia marcescens, which may lead to patient infections. CDC has confirmed growth of Serratia marcescens from several unopened syringes of this product in this specific AM2PAT lot. This type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries and/or death.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- New York, NY -- January 18, 2008 -- L'Oréal Paris, a division of L'Oréal USA, has initiated a voluntary recall from retail stores in the United States for the L'Oréal Paris Dream Blonde (Baby's Breath Blonde #100 Ultra Lightening) Bleach and Lightening care kit. The product was sold in retail outlets in the US from January 1 through January 18, 2008. L'Oréal is voluntarily taking this action due to an error in the printing of the directions for the use of the Dream Blonde Bleach and Lightening care kit. All retailers have been notified and have removed the product from their shelves. Affected consumers, estimated at a few hundred, will receive a full refund for returned product.
L'Oréal took immediate action following one customer complaint of the product causing irritation. The Dream Blonde Bleach and Lightening Care formula itself is safe. However, if used according to the current misprinted directions, complications such as irritation or sensitivity could result, so consumers should not use the product and should instead return it to their retailer for a refund. As with any product, if a consumer feels they are having any type of reaction or irritation, they should consultant their physician. This recall affects only the Dream Blonde Bleach and Lightening care kit in the Dream Blonde range of products.
Any consumers looking for more information should call 888-241-9504.
MacBook Air
As widely expected, Apple is launching an ultra-thin notebook called the MacBook Air. At 0.76" thick at its widest point, the three-pound Air has a wedgelike shape that tapers down to 0.16" thick at the front base. LED backlighting on its 13.3-inch screen, multi-touch trackpad (which offers some nifty features like rotating photos, all in the touchpad), and a backlit keyboard. Specs are decent: 1.6 or 1.8GHz Intel Core 2 Duo (on a cleverly shrunken socket), 2GB of RAM, and an 80GB hard drive (or 64GB SSD option). No optical drive (of course), and just one USB port. It'll set you back $1,799, which is on the inexpensive side for ultralight notebooks with specs like this. Ships in two weeks
FOR IMMEDIATE RELEASE -- December 31, 2007 -- Weis Markets today said it has initiated the voluntary recall of its Weis Baker's 18-count Fruit Miniatures and two pound platters of Mini-Fruit Diamonds in four varieties – Nut Diamond, Cheese Raspberry, Apricot and Mixed assortment. These products are being recalled because they may contain walnuts which are not identified on the label.
People who have an allergy or severe sensitivity to walnuts run the risk of serious or life-threatening allergic reaction if they consume these products.
These products, which were sold in Weis Markets' Bakeries, have been removed from store shelves and destroyed. The 18-count Fruit miniatures come in clear plastic containers and the two pound Mini Fruit Diamonds are packaged in a platter with a clear top. The UPC and code dates are listed below.
This problem came to the company's attention after a customer complaint. Concerned customers may return this product to Weis Markets for a full refund. Customers with concerns or questions about this recall may contact Weis Markets' customer hotline at 866-999-9347, Extension 3, which is open Monday through Friday 8 a.m. to 5 p.m.
Weis Baker's 18-count and two pound platters of Fruit Miniatures – Nut Diamond, Cheese Raspberry and Apricot are sold at Weis Markets including its Mr. Z's, King's and Scot's Lo-Cost units. Weis Markets operates 156 stores in five states: Pennsylvania, Maryland, New York, New Jersey and West Virginia.
The UPC Codes for the
recalled product with a sell by date up to 1/5/08 are:
UPC 210100-00000 18 Ct Fruit Miniatures
UPC 210112-00000 2 lb Fruit Miniature Platters
FOR IMMEDIATE RELEASE --Brooklyn, N.Y. -- Dec. 12, 2007 --- Kadouri International Foods, Inc. is recalling "King Brand Dried Turkish Apricots", because they contain undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatening reactions if they consume this product.
The product comes in 12.5 Kg. (28 lb) boxes marked with lot #35-105 on the side and with an expiration date of 15-07-2008 stamped on the side. The recalled "King Brand Dried Turkish Apricots" were distributed nationwide in retail stores and through mail orders.
The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis of the product by Food Laboratory personnel revealed the presence of undeclared sulfites in "King Brand Dried Turkish Apricots" in packages which did not declare sulfites on the label. The consumption of 10 milligrams of sulfites per serving has been reported to elicit severe reactions in some asthmatics. Anaphylactic shock could occur in certain sulfite sensitive individuals upon ingesting 10 milligrams or more of sulfites. Analysis of the "King Brand Dried Turkish Apricots" revealed they contained 70 mg per serving.
No illnesses involving this product have been reported to date to. Consumers who have purchased "King Brand Dried Turkish Apricots" are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at 1-718-381-6100.
FOR IMMEDIATE RELEASE -- December 12, 2007 -- Rochester, NY - Wegmans Food Markets, Inc. is initiating a voluntary recall of 8 oz. Wegmans Bouillabaisse Seafood Sauce with a ‘Use By’ date up to and including 12/24/07. The product is being recalled because it contains wheat, which is not declared on the label. The problem was identified by a routine label review. The recall of this product is of concern only to those individuals who have allergies to wheat or gluten sensitivity. Consumption may cause a serious reaction in persons with allergies to wheat.
The sauce is packaged in a clear, flexible pouch. All dates are affected by the recall. The product is no longer on store shelves.
No illnesses have been reported to date. Concerned customers should return the product to Wegmans for a full refund. Customers who have consumed the product and feel they are experiencing symptoms should contact their physician.
Wegmans Bouillabaisse Seafood Sauce is sold exclusively at Wegmans Food Markets’ 71 stores located in New York, Pennsylvania, New Jersey, Virginia and Maryland. Wegmans’ customers who have questions or concerns about this recall should contact the consumer affairs department Monday through Friday 8 a.m. through 5 p.m. at 1-800-WEGMANS, extension 4760.
FOR IMMEDIATE RELEASE -- December 7, 2007 -- Trader Joe's Company of Monrovia, California is voluntarily recalling 1,000 cases of 12 oz jars of Trader Joe's Pinjur (a traditional Macedonian condiment made with roasted peppers, eggplant, and tomatoes), UPC 00529068, Best By 10/2009. The Best By date can be found printed on the top of the lid. The product is being recalled because customers reported finding small pieces of glass in the product.
Trader Joe's Pinjur was potentially sold from Trader Joe's retail stores in Arizona, California, Connecticut, Delaware, Georgia, Illinois, Indiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, New Jersey, New Mexico, New York, Nevada, North Carolina, Ohio, Oregon, Pennsylvania, Virginia, Washington, Washington D.C., and Wisconsin.
Upon discovery of the problem, the product was removed from sale in all Trader Joe's stores and put on hold in all Trader Joe's distribution centers.
The product should not be consumed. Customers should discard it, or return it to any Trader Joe's store for a full refund. Customers with questions may call Trader Joe's Customer Relations at 626-599-3817, or write Trader Joe's through their website at traderjoes.com
FOR IMMEDIATE RELEASE -- December 7, 2007 -- Harry & David of Medford, Oregon, is voluntarily recalling approximately 50 jars each of the Oatmeal Chocolate Chip, Chocolate Peanut Butter and Cranberry Vanilla Chip cookie mixes because they may contain coconut, peanuts, milk and/or sulfites not declared on the ingredient statement. This product was made for Harry & David by Sisters’ Gourmet, Inc., a co-packer. People who have an allergy or severe sensitivity to these ingredients (coconuts, peanuts, milk and/or sulfites) run the risk of serious or life-threatening allergic reaction if they consume these products.
The products are packaged in 1 lb. 2 oz or 1 lb. 5 oz clear jars. The nutrition and ingredient information is contained inside hang tags attached to the top of the jars.
The recalled items may be quickly identified by checking for a match of the flavor description on the hang tag at the top of the jar with the flavor description on the price sticker on the bottom of the jar. Jars being recalled have flavor descriptions that DO NOT match.
Harry & David is recalling all Oatmeal Chocolate Chip cookie mix jars with bottom price stickers stating "Cookie Mix PB" or "Cookie Mix WC Cran". The potentially affected lot codes are 111207 or 110907 respectively.
Harry & David is
recalling all Chocolate Peanut Butter cookie mix jars with bottom price stickers
stating "Cookie Mix Oatmeal CC" or "Cookie Mix WC Cran". The potentially
affected lot codes are 111407 or 110907 respectively.
Harry & David is recalling all Cranberry Vanilla Chip cookie mix jars with
bottom price stickers stating "Cookie Mix Oatmeal CC" or "Cookie Mix PB". The
potentially affected lot codes are 111407 or 111207 respectively.
The lot codes are on stickers on the bottom of the jars.
The cookie mixes were distributed exclusively throughout the United States in Harry & David Stores, beginning on November 27, 2007.
There have been no injuries reported to date. Anyone concerned about a potential illness associated with this product should contact a physician immediately. This problem occurred when hang tags were applied to the wrong flavor of cookie mix.
Consumers with questions about the recalled product may phone the Customer Service division at 800-233-1101, 24 hours a day. Customers may arrange for refunds through this number as well.
Contact:
Gary Fort
615-444-3500
FOR IMMEDIATE RELEASE -- Lebanon , TN -- November 21, 2007 --- Le Gourmet Connection of Lebanon, TN is recalling Jack Cheese, lot number 539, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Jack Cheese Lot Number 539 was distributed in 10 ounce blocks and through Jungle Jim’s, Fairfield , Ohio.
This product was distributed between August 28, 2007 and November 19, 2007.
No illnesses have been reported.
The recall was the result of a routine sampling program by the Tennessee Department of Agriculture which revealed that the finished product contained the bacteria. The company has ceased the distribution of this lot as the company continues their investigation as to what caused the problem.
Consumers who have purchased this product are urged to discard it and to contact the company at (615) 444-3500 for a full refund.
THE PRESIDENT: Good morning. This week our Nation celebrated Thanksgiving. American families and friends gathered together to express gratitude for all that we have been given. We give thanks for the freedoms we enjoy. We give thanks for the loved ones who enrich our lives. And we give thanks for the many gifts that come from this prosperous land. Thanksgiving is a time when we acknowledge that all of these things, and life itself, come not from the hand of man, but from Almighty God.
Earlier this week, I visited Berkeley Plantation in Virginia. The story of this historic setting goes back nearly four centuries to another day of thanks. In 1619, a band of 38 settlers departed Bristol, England for Berkeley. At the end of their long voyage, the men reviewed their orders from home. The orders said, quote, "The day of our ship's arrival ... shall be yearly and perpetually kept holy as a day of Thanksgiving to Almighty God." In response, the men fell to their knees in prayer. And with this humble act of faith, the settlers celebrated their first Thanksgiving in the New World.
Berkeley's settlers remind us that giving thanks has been an American tradition from the beginning. At this time of year, we also remember the Pilgrims at Plymouth, who gave thanks after their first harvest in New England. We remember George Washington, who led his men in thanksgiving during the American Revolution. We remember Abraham Lincoln, who revived the Thanksgiving tradition in the midst of a terrible civil war.
Throughout our history, Americans have always taken time to give thanks for all those whose sacrifices protect and strengthen our Nation. We continue that tradition today -- and we give thanks for a new generation of patriots who are defending our liberty around the world. We are grateful to all our men and women in uniform who are spending this holiday weekend far from their families. We keep them in our thoughts and prayers. And we especially remember those who have given their lives in our Nation's defense.
One of these brave Americans was Lieutenant Michael Murphy. In June 2005, this officer gave his life in defense of his fellow Navy SEALs. Michael was conducting surveillance on a mountain ridge in Afghanistan, when his four-man SEAL team was surrounded by a much larger enemy force. Their only escape was down the side of the mountain. The SEALs launched a valiant counterattack while cascading from cliff to cliff. But as the enemy closed in, Michael recognized that the survival of his men depended on calling back to base for reinforcements.
With complete disregard for his own life, Michael Murphy moved into a clearing where he could get a signal. As he made the call, Michael fell under heavy fire. Though severely wounded, he said "thank you" before signing off, and returned to the fight. His heroism cost him his life -- and earned him our Nation's highest decoration for valor, the Medal of Honor. This weekend, we give thanks for the blessings of young Americans like Lieutenant Michael Murphy, who risk their own lives to keep us safe.
We're also blessed by the many other Americans who serve a cause larger than themselves. Each day our Nation's police and firefighters and emergency responders and faith-based and community volunteers dedicate their time to serving others. While we were enjoying our Thanksgiving turkeys, tens of thousands of these men and women were on the job -- keeping their fellow citizens safe and bringing hope and compassion to our brothers and sisters in need. And their sacrifice reminds us that the true strength of our Nation is the goodness and decency of our people.
Since America's first Thanksgiving, we have changed in many ways. Our population has grown. Our people have prospered. And we have become a great beacon of hope and freedom for millions around the world. Despite these changes, the source of all our blessings remains the same. We are grateful to the Author of Life who blessed our Nation's first days, who strengthened America in times of trial and war, and who watches over us today.
Thank you for listening.
Contact:
John Harrison
877-862-4332
FOR IMMEDIATE RELEASE -- Philadelphia, TN-- November 21, 2007 --- Sweetwater Valley Farms, Inc. of Philadelphia, TN is recalling Southern Cheddar Jack Volunteer Special Cheese because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Southern Cheddar Jack Volunteer Special Cheese, Lot Number 539 was distributed in 7, 10, 15 ounce, and 5 pound blocks and through retail stores in Tennessee, North Carolina, Georgia, Virginia, Maryland, and Alabama. The product was also distributed to 48 contiguous states in gift baskets marketed by the firm’s website.
This product was distributed between September 19, 2006 and November 18, 2007.
No illnesses have been reported.
The recall was the result of a routine sampling program by the Tennessee Department of Agriculture which revealed that the finished product contained the bacteria. The company has ceased the distribution of this lot as the company continues their investigation as to what caused the problem
Consumers who have purchased lot number 539 of this product are urged discard it or ship it back to the company for a full refund. Contact the company’s consumer affairs department at 1-877-862-4332 for further information.
Contact:
Mike Gloekler
(423) 238-7111, Ext. 22440
FOR IMMEDIATE RELEASE -- Collegedale, TN -- November 19, 2007 --- Blue Planet Foods Inc., of Collegedale, Tenn., is recalling 3,898 individual retail units of Heartland® brand Graham Pie Crusts because they contain undeclared almonds, milk and coconut. People who have an allergy or severe sensitivity to almonds, milk or coconut run the risk of serious or life-threatening allergic reaction if they consume these products.
The Heartland ® brand Graham Pie Crusts were distributed through retail stores nationwide.
The Heartland ® brand Graham Pie Crust is a ready-to-eat pie crust, packaged in a foil pie tin with clear plastic cover and labeled “Heartland ® Graham Pie Crust.” The pie crust has a net weight of 6 oz. (170g). Affected pie crusts are limited to those with freshness dates reading: “Best By Oct 27 2008 1” or “Best By Oct 27 2008 3.”
No illnesses have been reported. For most consumers, there is no safety issue with the pie crusts.
The recall was initiated after it was discovered that product containing almonds, milk and coconut was distributed in packaging that did not reveal the presence of almonds, milk and coconut. Subsequent investigation indicates that the problem was caused by a temporary application of an incorrect label.
Consumers who have purchased this product are urged to contact the company’s consumer affairs department toll-free at 1-877-885-6650 for a full refund.
Contact:
America True Man Health Incorporated
1-888-478-1888
FOR IMMEDIATE RELEASE -- November 16, 2007 - - American True Man Health Incorporated announced that it is expanding it's voluntary recall of the Company's dietary supplement product sold under the name and identified as True Man's Sexual Energy Nutriment Men's Formula with the expiration date up to and including December 2010 to also include the dietary supplement product sold under the name and identified as Energy Max, Energy Supplement Men's Formula (the products) with the expiration date up to and including December 2010. Finished products from several lots of these products were tested and were found to contain an analog of an ingredient in an FDA-approved drug. The analog resembles the active pharmaceutical ingredients in Tadalafil, Vardenafil, and Sildenefil, FDA-approved drugs used to treat erectile dysfunction (ED). Consequently, the products may possess a similar pharmacological and adverse event profile, posing a threat to consumers because of interaction with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, who may seek products to enhance sexual performance. Additionally, the product may cause side effects, such as headaches and flushing.
The recall is being done notwithstanding that the Company is unaware of any adverse effects having been reported or associated with the product.
Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.
The Company is advising consumers to return any unused product, for a full refund of the purchase price, to the retail location from which it was purchased, or to the Company directly if it was purchased from the Company. Consumers can call the Company at 1-888-478-1888 for instructions for returning the product.
Any adverse events that may be associated with the use of this product and/or quality problems should be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787; or on the MedWatch website at www.fda.gov/medwatch.
The Company is taking this voluntary action because it is concerned with individual health. The Company is working with the FDA in the recall process and is committed to the quality and integrity of its products. The Company has switched suppliers and is testing all shipments received before resale to customers and regrets any inconvenience.
| Southern California
Wildfires Burn Out of Control: New NASA Satellite Images Show Fires' Rapid
Growth |
10.23.07 |
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October 23, 2007 Update
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The Malibu area is experiencing a significant brush fire under windy conditions. At this time, no pepperdine structures have been lost although the brush fire continues to burn around portions of campus. The L.A. County Fire Department is on hand with two strike teams and continues to monitor the situation carefully. Steps have been taken to shelter and place all faculty, staff, and students in the Tyler Campus Center, Firestone Fieldhouse, and Payson Library. Conditions can change rapidly, so all faculty, staff, and students are urged to stay in the three assigned locations and stay off campus roads.
All scheduled events on the Malibu campus for Sunday, October 21 have been canceled.
Malibu Canyon is closed from Mulholland to PCH and PCH is closed between Topanga and Kanan.
Action Due to Possible E. coli O157:H7 Contamination
The recall is based on an investigation by the Minnesota Department of Health and Minnesota Department of Agriculture, as well as Cargill’s investigation and findings from a food safety assessment conducted by the U.S. Department of Agriculture at the Cargill Meat Solutions ground beef plant in Butler, Wis. Minnesota officials had investigated four cases of E. coli O157:H7 infection involving individuals who had consumed American Chef’s Selection Angus Beef Patties purchased at Sam’s Club stores in the state. While the investigation is ongoing, Cargill is voluntarily recalling the products based on a preliminary analysis of epidemiological data.
The products subject to the recall were produced on Aug. 9, 10, 15, 16 and 17, 2007, and were distributed nationwide. Each package bears the establishment number “Est. 924A” inside the USDA mark of inspection. The products include:
Products distributed at the retail and subject to recall are:
| 6-pound boxes of “American Chef's Selection Angus Beef Patties 18-1/3 Pound Patties.” Each package bears a case code of “7703100” and various package codes of Best If Used By dates of “02/05/08,” “02/06/08,” “02/12/08,” and “02/13/08.” |
Products distributed to restaurants and institutions and subject to recall include:
| 20-pound boxes of “Grille Works Seasoned Sirloin Steak Beef Patties.” Each package bears a case code of “7700296” and a package code “packed/chilled by 08/15/07.” | |
| 20-pound boxes of “TNT™ Thick ‘n Tender Beef Patties with Seasoning.” Each package bears a case code of “7703003” and a package code “packed/chilled by 08/15/07.” | |
| 20-pound boxes of “TNT Thick ‘n Tender Beef Patties with Seasoning.” Each package bears a case code of “7703008” and a package code “packed/chilled by 08/15/07.” | |
| 10-pound boxes of “TNT Thick ‘n Tender Beef Patties with Seasoning.” Each package bears a case code of “7703092” and a package code “packed/chilled by 08/15/07.” | |
| 20-pound boxes of “TNT Thick ‘n Tender Black Angus Beef Patties with Seasoning.” Each package bears a case code of “7703132” and a package code “packed/chilled by 08/15/07.” | |
| 20-pound boxes of “TNT Thick ‘n Tender Black Angus Beef Patties with Seasoning.” Each package bears a case code of “7703133” and a package code “packed/chilled by 08/15/07.” | |
| 10-pound boxes of “TNT Thick ‘n Tender Black Angus Beef Patties with Seasoning.” Each package bears a case code of “7703139” and a package code “packed/chilled by 08/15/07.” | |
| 20-pound boxes of “TNT Thick ‘n Tender Black Angus Ground Beef Patties.” Each package bears a case code of “7700922” and a package code “packed/chilled by 08/15/07.” | |
| 32.4-pound boxes of “100% Black Angus Ground Beef Patties.” Each package bears a case code of “7700932” and a package code “packed/chilled by 08/15/07.” | |
| 36.0-pound boxes of “100% Black Angus Ground Beef Patties.” Each package bears a case code of “7700983” and a package code “packed/chilled by 08/15/07.” |
“
We are concerned that some consumers may still have the product sold at retail in their freezers,” said Bill Rupp, president of Cargill Meat Solutions. “We and Sam’s Club are urging customers to return or destroy any American Chef’s Selection Angus Beef Patties purchased in any of their stores since August.”Rupp said the company learned of the situation shortly before noon on Friday. Based on information from Minnesota and USDA officials, the company investigated further and expanded the scope beyond Minnesota. Although the extent of any contamination is unknown, Cargill Meat Solutions has undertaken the voluntary recall as a proactive and cautionary step.
Consumers with questions about the recall should contact the company’s food safety line at 866-567-7899. Media with questions should contact the company’s media representative, Mark Klein, at 952-742-6211.
E. coli O157:H7 is a potentially deadly bacterium that can cause bloody diarrhea and dehydration. The very young, seniors and persons with compromised immune systems are the most susceptible to foodborne illness. Food safety experts recommend cooking any ground beef to an internal temperature of 160 degrees F., or until the meat is no longer pink and the juices run clear. Also, avoid contaminating other foods with any E. coli bacteria that may be present in meat by:
| Washing hands, utensils and cutting boards after they have been in contact with raw meat before they touch other food. | |
| Putting cooked meat on a clean platter, rather than on the other one that was used to hold raw meat. |
Consumers with food safety questions also can “Ask Karen,” the FSIS virtual representative available 24 hours a day at ASKKaren.gov. The toll-free USDA Meat and Poultry Hotline 1-888-MPHotline (1-888-674-6854) is available in English and Spanish and can be reached from 10 a.m to 4 p.m. (Eastern Time) Monday through Friday. Recorded food safety messages are available 24 hours a day.
Quong Hop & Co. of South San Francisco, Calif., is for the second time expanding its recall of tofu products, this time to include a new item and ones that have shelf-life dates until late November and late January.
The company recalled Saturday:
• The 30-ounce Soy Deli Vacuum Pack Firm Nigari tofu with the code dates Sept. 23, 2007, through Nov. 28, 2007. The product's original recall had the code date Sept. 23, 2007.
• The 12-ounce Soy Deli Vacuum Pack Firm Nigari tofu coded Sept. 23, 2007, through Jan. 28, 2008. The product's original recall had the code date Sept. 23, 2007.
• All Soy Deli Bulk Vacuum Pack Tofu, both the 10-pound and 25-pound products, with codes dates through Nov. 28, 2007.
The new recall also includes all varieties and sizes of the Soy Deli tofu coded Dec. 27, 2007, and the 16-ounce Quong Hop tofu, water packed, with the code date Sept. 23, 2007, which were announced in the original recall on Sept. 18.
The next day, the company expanded its recall to include products with two additional date codes that now fall within the recall products announced Saturday.
The products were distributed throughout the Midwest and the West Coast in supermarkets and natural food stores, the company said.
Healthy adults who are infected with listeria can experience symptoms including high fever, severe headache, nausea and diarrhea. For more information, consumers can call the company at 650-553-9900.
TWC Global LLC, Inc. Issues a Voluntary Nationwide Recall of Axcil and Desirin Products Marketed as Dietary Supplements
Contact:
TWC Global is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of Axcil and Desirin samples found the products contain potentially harmful, undeclared ingredients. FDA found the lot of 02B07 contains 3 mg/g of sildenafil, the active ingredient of a FDA-approved drug used for ED, as well as sulfosildenafil and sulfohomosildenafil, both are analogs of sildenafil. All of these undeclared chemicals pose a threat to consumers because they may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Sexual dysfunction is a common problem in men and women with these conditions, and consumers may seek these types of products to enhance sexual performance.
Both Axcil and Desirin are sold on internet nationwide. The products are sold as a 15-capsule blister pack packaged in a box.
Customers who have these products in their possession should stop using them immediately and contact their physician if they have experienced any problems that may be related to taking these products.
Any adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.
The company advises that any unused portion of the products be returned to TWC Global, LLC immediately for a full purchase price refund. The returning address is: TWC Global, LLC, 530 Showers Drive, Suite 7-129, Mountain View, CA 94040. Please return the unused portion of the product with invoice for refund. Consumers with questions may contact the company at 650-575-0828.
The Company is taking this voluntary action because it is committed and is always concerned with the health of consumers who have taken these products. The Company is reviewing the raw materials used to make these products and the raw material manufacturers and suppliers to identify the source of contamination to ensure that there will be no future issues with regard to Axcil and Desirin’s compositions. The Company is working closely with the FDA in the recall process and is committed to the quality and integrity of its products. It sincerely regrets any inconvenience to consumers.
Dole Fresh Vegetables Announces Voluntary Recall of 'Dole Hearts Delight' Packaged Salads
Contact:
Marty Ordman
1-818-874-4834
FOR IMMEDIATE RELEASE --Monterey, Calif. -- Sept. 17, 2007 --- Dole Fresh Vegetables, a division of Dole Food Company, Inc., today announced that it is voluntarily recalling all salad bearing the label "Dole Hearts Delight" sold in the U.S. and Canada with a "best if used by (BIUB)" date of September 19, 2007, and a production code of "A24924A" or "A24924B" stamped on the package. The "best if use by (BIUB)" code date can be located in the upper right hand corner of the front of the bag. The salad was sold in plastic bags of 227 grams in Canada and one-half pound in the U.S., with UPC code 071430-01038.
Symptoms of E. coli O157:H7 exposure could include stomach cramps and diarrhea. Bloody diarrhea may develop. E. coli disease sometimes leads to a complication called hemolytic uremic syndrome (HUS). If you exhibited any of these symptoms within 3 to 5 days of consuming any of the products specified above, seek medical attention.
To date, Dole has received no reports that anyone has become sick from eating these products. The recall is occurring because a sample in a grocery store in Canada was found through random screening to contain E. coli O157:H7. No other Dole salad products are involved.
Eric Schwartz, President, Dole Fresh Vegetables, stated: "Our overriding concern is for consumer safety. We are working closely with the U.S. Food and Drug Administration, the Canadian Food Inspection Agency, and several U.S. state health departments."
Consumers who may still have any of the "Dole Hearts Delight" salads with a "best if used by date" of September 19 and a production code of "A24924A" or "A24924B" should dispose of the product. This product was sold in Ontario, Quebec and the Maritime Provinces in Canada and in Illinois, Indiana, Maine, Michigan, Mississippi, New York, Ohio, Pennsylvania, Tennessee and neighboring states in the U.S. Consumers can call the Dole Consumer Center toll-free at 800-356-3111. Consumers are reminded that products should not be consumed after the "best if used by" date.
Dole Food Company, Inc., with 2006 revenues of $6.2
billion, is the world's largest producer and marketer of high-quality fresh
fruit, fresh vegetables and fresh-cut flowers. Dole markets a growing line of
packaged and frozen foods and is a produce industry leader in nutrition
education and research.
This release contains "forward-looking statements," within the meaning of the
Private Securities Litigation Reform Act of 1995 that involve a number of risks
and uncertainties. Forward looking statements, which are based on management's
current expectations, are generally identifiable by the use of terms such as
"may," "will," "expects," "believes,"
"intends" and similar expressions. The potential risks and uncertainties that
could cause actual results to differ materially from those expressed or implied
herein include weather-related phenomena; market responses to industry volume
pressures; product
and raw materials supplies
and pricing; changes in interest and currency exchange rates; economic crises
and security risks in developing countries; international conflict; and quotas,
tariffs and other governmental actions. Further information on the factors that
could affect Dole's financial results is included in its SEC filings, including
its Annual Report on Form 10-K.
#
FDA's Recalls, Market Withdrawals and Safety Alerts Page: http://www.fda.gov/opacom/7alerts.html
Strong America Limited Issues Alert on Undeclared Sulfites in Great Wall Brand Chinese Wolfberry
Contact:
Mr. Yang
(718) 628-6200
FOR IMMEDIATE RELEASE -- Long Island City, NY -- September 10, 2007 -- Strong America Ltd. of Long Island City, NY is recalling Chinese Wolfberry, because it may contain undeclared sulfites. People who have a severe sensitivity to sulfites run the risk of serious or life-threatening reactions if they consume this product.
The recalled Great Wall brand Chinese Wolfberry is packed in uncoded 7oz packages and were sold in GA, NY, and TN.
No illnesses have been reported to date.
The recall was initiated after routine sampling by the New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis by the Department’s Food Laboratory personnel revealed the presence of sulfites in the product, which were not declared on the label. The consumption of 10 milligrams of sulfites per serving has been reported to elicit severe reactions in some asthmatics; Anaphylactic shock could occur in certain sulfites sensitive individuals upon ingesting 10 milligrams or more of sulfites. Analysis of the Chinese Wolfberry revealed that it contained 12.87 milligrams per serving.
Consumers who have Great Wall brand Chinese Wolfberry can return the product to the place of purchase for a full refund. Consumers with questions may contact the company at 718-628-6200
Everlasting Distributors, Inc. Recalls Blue Ocean Smoked Indian Sardine Tamban Because of Possible Health Risk
Contact:
Richard Ng
201-823-0800
FOR IMMEDIATE RELEASE -- Bayonne, NJ -- August 29, 2007 -- Everlasting Distributors, Inc. of Bayonne, NJ, is recalling its Blue Ocean Smoked Indian Sardine Tamban 8oz. packaged frozen products because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.
Botulism, a potentially fatal form of food poisoning, can cause the following symptoms: general weakness, dizziness, double-vision and trouble with speaking or swallowing. Difficulty in breathing, weakness of other muscles, abdominal distension and constipation may also be common symptoms. People experiencing these problems should seek immediate medical attention.
Blue Ocean Smoked Indian Sardine Tamban was distributed in New York and New Jersey areas and it reached consumers through retail stores.
Blue Ocean Indian Sardine Tamban comes in an uncoded white styropor foam tray and vacuum packed with a clear plastic bag.
The potential for contamination was noted after routing testing.
No illnesses have been reported to date in connection with this problem.
Consumers who have purchased the Blue Ocean Smoked Indian Sardine Tamban 8oz. frozen product are urged to return them to the place of purchase for a full refund. Consumers with questions may contact Everlasting Distributors, Inc. at (201) 823-0800.
Urgent: Abbott Notifies Users of Precision Xtra™, Optium™, ReliOn® Ultima, Rite Aid® and Kroger® Blood Glucose Meters to Check Display Screens
Contact:
Tama Antonia Donaldson
(510) 749-5449
FOR IMMEDIATE RELEASE -- Alameda, CA -- August 31, 2007 -- Abbott is initiating a worldwide medical device correction for users of its Precision Xtra™, Optium™, ReliOn® Ultima, Rite Aid® and Kroger® blood glucose meters manufactured after January 31, 2007. If the meter is dropped on a hard surface, part or all of the display screen may not work properly or may appear blank, which could result in an inability to view blood glucose test results. The inability to generate blood glucose results could result in significant risk for hypoglycemia or hyperglycemia.
Users of these meters who note that the display screen is not working properly should immediately stop using their meter as referenced in the User Guide and call Abbott Diabetes Care customer care for assistance at 1-877-844-4404. Through internal testing, Abbott Diabetes Care has found that when recently produced meters are dropped onto a hard surface, part of the display can be jarred or disconnected, thereby making it difficult to read the lot number or date information, or causing the screen to appear blank. No injuries have been reported to date.
Patients should keep their glucose meters in the wallet provided to offer additional protection for the meter. If the meter is dropped on a hard surface, patients should immediately perform a meter display check. Instructions on how to do this are detailed in the meter’s Users Guide. If no problems are encountered during the automatic display check, the meter is ready for use. Customers may call Abbott Diabetes Care customer care at 1-877-844-4404 to determine the date their meter was manufactured. Customers may also call customer care if they have questions or need a replacement meter.
Precision Xtra™, Optium, ReliOn® Ultima, Rite Aid® and Kroger® blood glucose meters have been distributed via retail and mail order pharmacies, physician offices and distributors. Abbott is notifying physicians, pharmacists, distributors and registered users by letter.
Blood glucose test strips used with these meters are not affected by this notification.
More information about this notification is available on the company’s website, www.abbottdiabetescare.com.
Contact:
Steve Lyle
916-654-0462
FOR IMMEDIATE RELEASE -- Sacramento, CA -- September 7, 2007 -- The California Department of Food and Agriculture has issued an order to Organic Pastures Dairy Company to withdraw from retail distribution Grade A raw cream manufactured at their facility in Fresno, due to detection of Listeria monocytogenes bacteria.
Under the recall, Organic Pastures brand Grade A raw cream with code dates SEP 14 through SEP 21 is to be pulled immediately from retail shelves and consumers are strongly urged to dispose of any product remaining in their refrigerators. Until further notice, Organic Pastures may not produce raw cream for the retail market.
The quarantine order came following laboratory confirmation of Listeria monocytogenes bacteria. CDFA inspectors found the bacteria as a result of product testing conducted as part of routine inspection and sample collection at the facility.
The withdrawal order involves removal of raw cream from grocery stores, retail outlets and farmers markets throughout California.
The great majority of cream consumed in California is
pasteurized. Raw cream is not. Pasteurization eliminates the risk of bacterial
illness.
Listeria monocytogenes may cause listeriosis among "at risk" people,
including pregnant women, newborns, older adults, and people with weakened
immune systems. Symptoms include fever, muscle aches, and sometimes nausea or
diarrhea. If infection spreads to the nervous system, symptoms such as headache
and stiff neck can occur. Infected pregnant women may experience only a mild,
flu-like illness; however, infections during pregnancy can lead to more serious
problems for the fetus. Consumers should seek immediate medical care if they
develop these symptoms.
Consumers should discard the raw cream or return it to the place of purchase for a refund. California consumers who have purchased Organic Pastures brand raw cream may call the company at 559- 352-6585 with questions about the product withdrawal.
####
Contact:
Bodee LLC
help@zencoretabs.com
FOR IMMEDIATE RELEASE -- Century City, CA – August 31- Bodee LLC, 2222 Avenue of the Stars, 702E, Century City, CA 90067, announced today that it is conducting a voluntary nationwide recall of all the company's supplement product sold under the name Zencore Tabs.
Bodee LLC is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of Zencore Tabs samples found the product contains potentially harmful, undeclared ingredients. FDA asserts that its chemical analysis revealed that one lot of Zencore Tabs contains aminotadalafil, an analog of tadalafil, the active ingredient of a FDA-approved drug used for Erectile Dysfunction (ED). FDA maintains Aminotadalafil is close in structure to tadalafil and is expected to possess a similar pharmacological and adverse event profile. Further, FDA declares another lot of Zencore Tabs contains sildenafil, the active ingredient of another FDA-approved drug used for ED, as well as sulfosildenafil and sulfohomosildenafil, both are analogs of sildenafil. All of these undeclared chemicals pose a threat to consumers because they may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.
Zencore Tabs is sold in health food stores and by mail order nationwide and in Canada. The Zencore Tabs product is sold as a 2-capsule blister pack packaged in a retail booklet with five booklets in a box.
Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.
Any adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.
The company advises that any unused portion be returned to Bodee LLC for a full purchase price refund by calling (800) 935-0296 for instructions on the return and refund process.
The Company is taking this voluntary action because it is committed and is always concerned with the health of persons who have consumed this product. The Company is reviewing the procedures and policies of all firms involved with the manufacture of the product to ensure that there will be no future issues with regard to Zencore Tabs’ composition. The Company is working closely with the FDA in the recall process and is committed to the quality and integrity of its products. It sincerely regrets any inconvenience to consumers and its other customers
.Contact:
Communications Office
614-752-9817
FOR IMMEDIATE RELEASE -- August 31, 2007 -- Ohio Department of Agriculture (ODA) Director Robert Boggs in conjunction with The Kroger Co. today advises consumers not to consume Kroger brand Mustard or Southern-Style potato salad with a "Best If Used By" date of Sept. 5, 2007, because it may contain E. coli O157:H7.
ODA’s Consumer Analytical Laboratory tested a sample of the Kroger brand Mustard or Southern-style potato salad collected during routine food safety sampling, and found it positive for E. coli O157:H7, a foodborne pathogen.
To date, no illnesses have been reported, and additional samples analyzed by a certified, thirdparty laboratory contracted by Kroger have tested negative for E. coli O157:H7. As a precautionary measure, The Kroger Co. has removed the product from sale. The company encourages consumers to check their refrigerators and freezers for this specific product and, if found, to return it to the store for a full refund.
For more information regarding this product withdrawal, please visit www.kroger.com.
Through ODA’s Division of Food Safety, the department helps assure consumers are provided foods, over-the-counter drugs, dietary supplements, and cosmetics that are safe, unadulterated, and honestly presented. Random, routine testing at the department's Consumer Analytical Laboratory helps identify potentially dangerous or adulterated products. In addition to advising consumers, the department has notified the Food and Drug Administration and local health departments.
####
Stirrings LLC Participates in Voluntary Nationwide Recall of Rimmer® Brand Mojito Cocktail Garnish Due to Possible Health Risk from Contaminated Raw Ingredient Supplied by Van de Vries Spice Corporation
Contact:
Paul Nardone
508-324-9800
Stirrings LLC, of Fall River, Massachusetts is recalling its 3.5 oz packages of Rimmer® Brand Mojito Cocktail Garnish (UPC# 80999 00046) with the best by codes 10/27/08, 10/30/08, 11/23/08, 12/01/08, 12/04/08 and 01/03/09 printed on the side of the tin. The recall may involve approximately 5,000 cases of its Rimmer® Brand Mojito Cocktail Garnish supplied by Van de Vries Spice Corporation (formerly Atlantic Quality Spice) of Edison, NJ because they have the potential to be contaminated with Salmonella. Although Stirrings LLC's tests of finished product samples were negative for the presence of Salmonella, parsley powder, one of several ingredients supplied by Van de Vries Spice, tested positive for Salmonella.
The presence of Salmonella can cause serious and sometimes fatal infections in young children, frail, or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting, and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more serious illnesses such as arterial infections (i.e. infected aneurysms), endocarditis and arthritis.
Rimmer® Brand Mojito Cocktail Garnish was distributed nationwide through distributors, retail stores, internet sales and cocktail establishments.
Immediately after Van de Vries brought to Stirrings attention that a parsley powder used in a single lot of Mojito Rimmer product potentially could contain Salmonella based on FDA testing, Stirrings retained expert laboratories, primarily Shuster Laboratories of Canton, Massachusetts to test samples of its Mojito Rimmer product for Salmonella. Testing of 24 samples drawn from the Van de Vries lot of Mojito Rimmer failed to reveal the presence of Salmonella in the Mojito Rimmer product.
No illnesses have been reported to date.
Stirrings CEO Paul Nardone explained, "We have removed parsley powder from our Rimmer Cocktail Garnish formula. This ingredient represents less than one half of one percent of the blend and was used primarily as a natural colorant." Nardone further stated, "We have initiated a recall as a precaution and assurance to our customers that we stand behind our product quality 100%."
Consumers who have purchased Rimmer® Brand Mojito Cocktail Garnish with the best by codes noted above are asked to return it to the place of purchase for a full refund. Consumers with questions may contact the Company toll-free at 866-648-8239.
The U.S. Food and Drug Administration is warning consumers not to eat raw oysters harvested from an additional part (growing area 5) of the southern tip of Hood Canal in Washington state due to a foodborne illness outbreak caused by Vibrio parahaemolyticus bacteria. This follows an earlier outbreak and August 10 warning about oysters harvested from growing area 6 of Hood Canal.
Symptoms of the illness, vibriosis, include watery diarrhea, often with abdominal cramping, nausea, vomiting, fever, and chills. Usually these symptoms occur within 24 hours of ingestion and last no more than three days. Severe disease is rare and occurs most commonly in people with weakened immune systems. Those who believe they have experienced these symptoms after consuming raw oysters should consult their health care provider and contact their local health department.
Raw oysters harvested from growing area 5 in Hood Canal from July 31 through August 20, 2007 have caused at least six people to become ill in Washington state. To date, records indicate that raw oysters from the area were distributed to Arizona, California, Colorado, Delaware, Florida, Idaho, Minnesota, New York, Oregon, Pennsylvania, Utah, Washington state, British Columbia (Canada). Bali (Indonesia), Hong Kong, Singapore, and Thailand.
The Washington State Department of Health has closed the growing area associated with the illness and has asked commercial oyster harvesters and dealers who obtained oysters from this area to recall them.
Consumers who have recently purchased oysters should check with the place of purchase and ask if they were harvested from the affected growing areas. The recall involves both shucked oysters and oyster in the shell (shell stock oysters).
Those with weakened immune systems, including people affected by HIV/AIDS, chronic alcohol abuse, liver, stomach, or blood disorders, cancer, diabetes, or kidney disease, should avoid eating raw oysters, regardless of where they are harvested.
FDA advises that consumers can continue to enjoy oysters in many cooked preparations by doing the following:
At Restaurants and other Foodservice Establishments:| Order oysters fully cooked. |
In the Shell:
| Purchase oysters with the shells closed | |||||||||
| Throw away any oysters with shells already opened. | |||||||||
| Never allow raw seafood to come into contact with cooked food. | |||||||||
Boil or steam the
oysters:
|
Shucked Oysters:
| Never allow raw seafood to come into contact with cooked food. | |||||||||
Cook the oysters in
one of the following ways:
|
For more information:
Hood canal oyster area closed — second closure due to illness outbreak
www.doh.wa.gov/Publicat/2007_news/07-143.htm
Contact:
Metz Fresh
831-386-1018
FOR IMMEDIATE RELEASE -- Salinas, CA -- August 28, 2007 -- Metz Fresh, LLC is voluntarily recalling bagged spinach as a result of a positive test for Salmonella found during routine company testing.
The spinach is distributed under the label Metz Fresh, in both retail and food service packages. These include 10 and 16 oz bags as well as 4-2.5 lb. and 4 lb. cartons. The only Metz Fresh product affected is spinach that bears the tracking codes 12208114, 12208214 and 12208314. It was distributed in the continental United States and Canada.
There have been no reports of illness or problems related to this spinach.
Salmonella is a common food borne pathogen that can cause severe illnesses, including fever, abdominal cramps and diarrhea. While most individuals recover in three to five days without medical intervention, the infection can be life-threatening to young children, the elderly and those with compromised immune systems. Consumers with any of these symptoms should call their physician.
Consumers are advised to discard this product or return it to the place of purchase for a refund. Consumers with questions about the recall should contact 831-386-1018.
"Nothing is more important to Metz Fresh than the safety of our consumers, period," said Andrew Cumming, President of Metz Fresh. "As soon as we learned of the presumptive positive test, we directed all customers to hold all boxes of the spinach affected as a precaution. Now, with this positive test confirmation, there is no question that we would recall and destroy all spinach bearing these three codes."
The positive test came during independent lab testing Metz Fresh conducts on all of its products. Through its labeling and numbering system, Metz Fresh has already tracked, located and put 'holds' on the vast majority of the cartons of spinach affected. That spinach will not be released into the marketplace.
While the positive test came from only one sample of many on three packing lines, Metz Fresh has, as a precaution, chosen to recall all of the spinach from the ‘field lot’ packed that day on all three lines.
Metz Fresh is keeping appropriate authorities updated on the status of the voluntary recall.
The U.S. Food and Drug Administration is alerting consumers that Mars Petcare US, Inc. has recalled two dry dog food products because of the potential contamination with Salmonella Schwarzengrund.
The Mars Petcare US, based in Franklin, Tenn. is voluntarily recalling five-pound bags of Krasdale Gravy dry dog food sold in Connecticut, Massachusetts, New Jersey, New York, and Pennsylvania, and 50-pound bags of Red Flannel Large Breed Adult Formula dry food sold in Pennsylvania.
The FDA conducted tests on 10 samples, representing seven product brands from the company. Each sample (same size and brand of product) consisted of 15 subsamples, for a total of 150 subsamples. Tests of the 150 subsamples revealed two positive samples; one from the Krasdale Gravy dry food and another from Red Flannel Large Breed Adult Formula dry food.
Salmonella can potentially be transferred to people handling pet food, especially if they have not thoroughly washed their hands after having contact with the product or any surfaces exposed to the product. To date, there have been 64 cases of illness in humans related to Salmonella Schwarzengrund reported to the U.S. Centers for Disease Control and Prevention (CDC); however, none of the reported cases have been directly linked to the recalled product that was tested. The FDA is working with local and state officials, and with officials at the CDC in the investigation.
Here is identification information on the recalled products:
Product: Krasdale Gravy dry dog food
Size: Five-pound bag
UPC Code: 7513062596
Best By Date: July 16, 2008 & July 17, 2008
Best By Date Location: Back of bag
Distribution: Stores in Connecticut, Massachusetts, New Jersey,
New York, and Pennsylvania
Product: Red Flannel Large Breed Adult
Formula dry dog food
Size: 50-pound bag
UPC Code: 4286900062
Best By Date: July 12, 2008
Best By Date Location: Back of bag
Distribution: Stores in Reedsland and Richlandtown, Pa.
Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Well animals can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.
Consumers with questions about the recalled product should call Mars Petcare US, Inc. at 866-298-8332.
For more information:
Safe Handling Tips for Pet Foods and Treats
Contact:
John Shaughnessy
626-322-9017
FOR IMMEDIATE RELEASE -- Industry, CA -- August 22, 2007 -- Los Angeles Salad Company, located in City of Industry, CA is recalling its "Genuine Sweet Baby Carrots" with a Sell By Date Code up to and including August 16, 2007 printed on the back of the packages because the product may be contaminated with the bacteria Shigella. Shigella infection can cause diarrhea (which may be bloody), fever, nausea and vomiting. Illness usually lasts from 4 to 14 days. In some persons, especially the very young, the very old and people with compromised immune systems, the diarrhea can be more severe. Infection can occur after eating and drinking food and water that is contaminated with Shigella and can be passed from person to person.
The product was sold in packages with two labels. One is labeled "Los Angeles Salad Genuine Sweet Baby Carrots" distributed by Kroger Co. King Sooper, in Colorado, Kroger Co. Ralphs in California; Publix in Georgia, Tennessee, Alabama, South Carolina and Florida. All of these packages were sold in flexible plastic bags in 7 and 8 oz. size with a Sell By Date Code up to and including August 16, 2007. The second label was "Trader Joe's Genuine Sweet Baby Carrots" distributed by Trader Joe's in Arizona, California, New Mexico, Nevada, Oregon and Washington in 7 oz. flexible plastic bags with a Sell By Date Code up to and including August 8, 2007.
The recall was initiated after it was discovered that the same product sold in Canada was contaminated with Shigella. There were four reported incidences of illness in Canada from August 4-6, 2007. No one was hospitalized and all persons affected have fully recovered. An ongoing investigation is being conducted to find the cause of the problem, but at this time the source has not been determined.
This is precautionary notice. Consumers who have purchased Los Angeles Salad Company's "Genuine Sweet Baby Carrots" are urged to return it to the place of purchase for a full refund. Consumers with questions may contact Los Angeles Salads at (1-626-322-9017).
####
MATTEL PROVIDES INSTRUCTIONS ON HOW AND WHERE
TO RETURN TOYS AFFECTED BY RECALL
Mattel issues information to correct inaccurate reports
Mattel advises consumers to not return products to retailers
STEPS TO RETURN A MATTEL TOY THAT IS AFFECTED BY THE AUGUST RECALLS, ANNOUNCED IN COOPERATION WITH THE U.S. CONSUMER PRODUCT SAFETY COMMISSION:
1) The first step is for consumers to determine if they have a toy that has been affected by the recall. To do so, they can visit www.service.mattel.com where they will find a complete list of each toy recalled, including color photos and toy model numbers. Consumers can locate toy model numbers on most recalled toys.
For consumers without a computer, or for those preferring phone support, they may call the following hotlines dedicated to the different product recalls:
2) Once consumers determine if they think they own a Mattel toy affected by the recall, they are prompted to fill out a form (online) or provide their postal address (via phone), and Mattel will send to consumers (via email or to a postal address) a color brochure with photos and toy numbers of every affected toy, as well as a pre-paid mailing label for return of the affected toys.
3) After receiving consumers’ returned, affected toys, Mattel will send vouchers to consumers for the amount of the toy(s)’ original value or a replacement part (if applicable). Vouchers may be used at most national retailers and are good toward any Mattel or Fisher-Price manufactured product.
Consumers do not need to have the toy’s original packaging or a receipt to return affected products to Mattel.
# # #
Jose Padilla was convicted of federal terrorism support charges Thursday after being held for 3 1/2 years as an enemy combatant in a case that came to symbolize the Bush administration's zeal to stop homegrown terror.
The Chicago native was once accused of being part of an al-Qaida plot to detonate a radioactive "dirty bomb" in the U.S., but those allegations were not part of his trial with two co-defendants.
Padilla, Adham Amin Hassoun and Kifah Wael Jayyousi face life in prison because they were convicted of conspiracy to murder, kidnap and maim people overseas. All three were also convicted of two terrorism material support counts that carry potential 15-year sentences each.
U.S. District Judge Marcia Cooke set a Dec. 5 sentencing date for all three defendants.
The three were accused of being part of a North American support cell that provided supplies, money and recruits to groups of Islamic extremists. The defense contended they were just trying to help persecuted Muslims in war zones with relief and humanitarian aid.
Contact:
Cindy Duran, Borshoff Johnson Matthews
(317) 631-6400, ext.
237
FOR IMMEDIATE RELEASE -- Indianapolis, IN -- August 13, 2007 -- Gilchrist & Soames, an Indianapolis-based provider of toiletry products for the hotel industry, has initiated a worldwide voluntary recall of its Gilchrist & Soames 0.65oz/18ml toothpaste manufactured in China for the company by Ming Fai Enterprises International Co., LTD, after independent tests showed some samples of the toothpaste contained diethylene glycol, or DEG.
The United States Food and Drug Administration ("FDA") is not aware of any U.S. reports of poisonings from toothpaste containing DEG. However, the agency is concerned about potential risks from chronic exposure to DEG and exposure to DEG in certain populations, such as children and individuals with kidney or liver disease. DEG in toothpaste has a low but meaningful risk of toxicity and injury to these populations. Toothpaste is not intended to be swallowed, but FDA is concerned about unintentional swallowing or ingestion of toothpaste containing DEG. This voluntary recall is being conducted in cooperation with the FDA. The Company also has notified the Department for Business, Enterprise and Regulatory Reform in the UK to enable it to notify the European Commission to launch a RAPEX notification in the European Union.
Hotels in the United States, Canada, Mexico, Bermuda, Barbados, Dominican Republic or Turks & Caicos that received the recalled toothpaste from the company’s United States distribution center, and those located in the U.K., Ireland, Spain, Belgium, France, Italy, Germany, Switzerland and the UAE serviced by the company’s U.K. distribution center, are being asked to destroy any remaining inventory.
Hotel guests, who may have received the recalled toothpaste from hotels in any of these countries, should safely dispose of it.
"After receiving the FDA alert June 1 about tainted toothpaste manufactured in China, we immediately contacted our two Chinese toothpaste suppliers and initiated a series of independent lab tests in both Hong Kong and the United States to determine the possible presence of DEG," said Kathie De Voe, president of Gilchrist & Soames.
At the same time, Gilchrist & Soames stopped all outgoing shipments and quarantined all of its "Made in China" toothpaste. The Company also communicated with all of its hotel clients and suggested that they stop offering Chinese-made Gilchrist & Soames toothpaste to their guests until further investigation and independent testing by Gilchrist & Soames and the FDA. The June 1 FDA Consumer Alert was attached. The Company took these steps even though its toothpaste was not among those cited in the FDA warning.
De Voe said, "The fifth round of our independent lab tests showed the presence of DEG in some samples at levels exceeding FDA guidelines from one of our China suppliers. We immediately began the process of initiating a voluntary recall of our complimentary-sized (.65oz/18ml) Gilchrist & Soames toothpaste. We want to ensure that any contaminated toothpaste is safely disposed of and/or destroyed."
Gilchrist & Soames is notifying its hotel clients in those countries where the toothpaste was distributed to discard their inventories. The Company is working with each hotel on a guest notification program. Materials will inform guests about this voluntary recall, including the FDA Web address for current toothpaste recalls (http://www.fda.gov/oc/opacom/hottopics/toothpaste.html), as well as a toll-free telephone number at Gilchrist & Soames U.S. headquarters (1-866-587-6542) that hotel guests may call if they desire more information about the recall. The European Union Web address for further information about toothpaste manufactured in China is http://ec.europa.eu/consumers/dyna/rapex/rapex_archives_en.cfm. Local contact numbers in Europe for Gilchrist & Soames are as follows: Germany – 004908000004988, Ireland – 00353 1800932251, France – 0033 0805114958, Spain – 0034800098797, Switzerland - 0041 0800 001285, Hungary – 0036 0680018077, Italy – 0039 800986779, UK – 08003112139, Belgium – 0032 080048630.
De Voe said, "We are thankful that the small size of our tubes (.65oz/18ml) may help reduce the risk. However, we strongly encourage consumers to dispose of any of the recalled toothpaste they may still have."
Gilchrist & Soames is working with its global supply chain partners to be certain they meet the standards and specifications outlined in its new testing criteria. New testing to confirm the absence of DEG will be part of that process. This recall is being conducted with the knowledge of the FDA, and the European Authorities.
CFS Operating Ltd. DBA/Cloud's Food Service Inc., Recalls Sandwiches Because of Possible Health Risk
Contact:
David Floyd
(903) 758-7011
FOR IMMEDIATE RELEASE -- Longview, TX – August 7, 2007, CFS Operating Ltd. of Longview, Texas is recalling 4219 units of Cloud's Tuna Salad Sandwiches and Egg Salad Sandwiches because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
These sandwiches are labeled with "Cloud's Tuna Salad" and "Cloud's Egg Salad" located on the product label. The product was packaged in flexible plastic film and plastic wedges. Recalled products are as follows:
All sandwiches were sold in convenience stores in East Texas, West Louisiana and Southwest Arkansas.
There have been no reports of illnesses associated with the recalled product. The problem was discovered through FDA sampling during an inspection. CFS Operating Ltd. is working with the FDA to ensure that the problem has been resolved.
Consumers who have purchased Cloud's Tuna Salad and Cloud's Egg Salad sandwiches are urged to return it to the place of purchase for a full refund. Consumers with questions may contact David Floyd at (903) 758-7011.
Baxter Provides Update on Service Documentation Class I Recall
Models Include: COLLEAGUE Mono Volumetric Infusion pump, Product Codes 2M8151 and 2M8153; COLLEAGUE CX Volumetric Infusion pump, Product Codes 2M8161 and 2M8163; FLO-GARD 6201 Volumetric Infusion pump, Product Code 2M8063; and FLO-GARD 6301 Volumetric Infusion pump, Product Code 2M8064
Contact:
Baxter Healthcare Corporation
1-800-843-7867
FOR IMMEDIATE RELEASE -- DEERFIELD, Ill., August 7, 2007 – Baxter Healthcare Corporation today announced an update to the July 25, 2007 Class I recall press release regarding falsified repair, test and inspection data sheets, which included electrical safety data for COLLEAGUE and FLO-GARD infusion pumps. Baxter has expanded the recall to include an additional 986 COLLEAGUE infusion pumps, which need to be returned to the company for repeat inspection, because of falsified electrical safety data.
As announced on July 25, 2007, in the course of its ongoing quality control processes, the company discovered falsified service documentation data. Therefore, it is possible that pumps sent to be serviced, repaired or corrected were returned without service being performed on them. Previously, the recall pertained to 534 infusion pump devices serviced in the company's Phoenix, Arizona service center. The expansion of the recall represents pumps serviced by all three employees previously mentioned who have been dismissed. Baxter's investigation of the matter is continuing. The company will continue to provide updates and instructions to users regarding the service documentation recall on www.baxter.com.
The company has informed all customers to contact Baxter and return affected pumps for repeat inspection and servicing and will provide loaner pumps free of charge. There are no serious injuries or patient deaths associated with this action to date. This recall action impacts only pumps distributed in the United States.
This issue was classified by FDA as a Class I recall on July 24, 2007, because of the potential risk of serious injury or patient death if affected devices malfunction. A defect may result in over-infusion, under-infusion, failure to detect an upstream or downstream occlusion, electrical shock hazard, failure to detect air in line, and malfunctions where the pump will stop infusing and result in an interruption of therapy. Affected model numbers include: FLO-GARD Model Numbers 6201 and 6301 Volumetric Infusion pump, Product Codes: 2M8063 and 2M8064; COLLEAGUE Volumetric Infusion pump, Product Codes: 2M8151 and 2M8153; and COLLEAGUE CX Volumetric Infusion pump, Product Codes: 2M8161 and 2M8163. The Agency is expected to issue a Preliminary Public Health Notification on Baxter's service documentation recall.
Customers with questions regarding this notice or who have affected pumps should contact Baxter at 1-800-843-7867 (1-800-THE-PUMP) and arrange for a repeat servicing and inspection or for loaner devices, free of charge. Representatives are available Monday through Friday from 7 a.m. to 5 p.m.
CDT.
Cost Plus World Market Recalls Red, Blue, Green, and Yellow Speckleware Beverage Containers and Glass Water Tank For Potential Lead Exposure Risk
– Cost Plus World Market, a leading retailer of casual home living and entertaining products, today announced a voluntary recall of the following consumer products: Red, blue, green, and yellow speckleware beverage containers with SKU numbers 370549, 391163, 378321, 378322; and glass water tank retro w/spout with SKU number 378251. These numbers appear on the customer sales receipt. These items are being recalled because the metal spigot used in these containers can leach lead into lemonade and other acidic beverages stored in them. This does not occur if water is used in the beverage containers. No illnesses have been reported to date.
There were approximately 12,592 units sold at Cost Plus/World Market stores nationwide from May 2005 through July 2007 for between $19.98 and $39.99.
According to the FDA, lead is very toxic and dangerous to humans, especially children, women of childbearing age, pregnant women and their unborn children. Although people with lead in their blood often do not exhibit the symptoms of lead toxicity, such symptoms include the following: stomach aches, colic, nausea, vomiting, abnormal irritability, and insomnia. Lead can also permanently damage the central nervous system, resulting in learning difficulties in school children as well as cause other long-term health problems.
Customers who have purchased these beverage containers are urged to return them to any Cost Plus World Market store for a full refund.
Consumers who may have questions or concerns should contact Cost Plus Inc. at (877) 967-5362 between 7:00 a.m. and 12:00 a.m. EDT any day or at www.worldmarket.com
FDA Warns of Potential
Botulism Risk from Canned French Cut Green Beans
Product Marketed
Under a Variety of Brand Names
The U.S. Food and Drug Administration (FDA) is warning consumers not to eat certain brands of French Cut Green Beans in 14.5 ounce cans manufactured by Lakeside Foods Inc, of Manitowoc, Wisconsin because the product may not have been processed adequately to eliminate the potential for botulism toxin. This warning is not related to another recent warning for botulism.
The canned green beans may cause botulism if consumed. FDA is providing this warning to make consumers aware of the possible risk of serious illness from eating these products. As of August 1, 2007, FDA had not received reports of illnesses related to the product.
The botulism toxin is very potent, and botulism is a life-threatening illness. Symptoms of botulism can begin from six hours to two weeks after eating food that contains the toxin. The symptoms may include double vision, blurred vision, drooping eyelids, slurred speech, difficulty swallowing, dry mouth, and muscle weakness that moves progressively down the body, affecting the shoulders first then descending to the upper arms, lower arms, thighs, and calves. Botulism also may cause paralysis of the breathing muscles, which can result in death unless assistance with breathing (mechanical ventilation) is provided. Individuals who show these symptoms and who may have recently eaten the product should seek immediate medical attention.
The affected Lakeside cut green beans are sold nationwide under the following labels: Albertson's, Happy Harvest, Best Choice, Food Club, Bogopa, Valu Time, Hill Country Fare, HEB, Laura Lynn, Kroger, No Name, North Pride, Shop N Save, Shoppers Valu, Schnucks, Cub Foods, Dierbergs, Flavorite, IGA, Best Choice and Thrifty Maid. The specific codes (top line of can code) involved are: EAA5247, EAA5257, EAA5267, EAA5277, EAB5247, EAB5257, ECA5207, ECA5217, ECA5227, ECA5297, ECB5207, ECB5217, ECB5227, ECB5307.
Consumers who have any
of these products or any foods made with these products should dispose of them
immediately. If the code on an affected can is missing or unreadable, consumers
should throw the product out.
Lakeside Foods has informed FDA that it is voluntarily recalling all of the
potentially contaminated products.
Lakeside Foods recommends that consumers with any questions or concerns about the recall should call the company at 800-466-3834 ext. 4090.
Bridge collapses into Miss. River
Entire span of a four-lane interstate bridge over the Mississippi River collapsed during evening rush hour Wednesday, sending vehicles, tons of concrete and twisted metal crashing into the water.
The Interstate 35W bridge, which spans between Minneapolis and St. Paul, was under construction when it broke into several huge sections. Dozens of vehicles were scattered and stacked on top of each other amid the rumble.
California Department of Public Health Warns Consumers Not to Eat Fresh Ginger From China
FOR IMMEDIATE RELEASE -- Sacramento, CA -- July 29, 2007 -- Dr. Mark Horton, director of the California Department of Public Health (CDPH), today warned consumers not to eat fresh ginger imported from China after the California Department of Pesticide Regulation’s residue monitoring program detected the presence of aldicarb sulfoxide in some batches of imported ginger. Aldicarb sulfoxide is a pesticide that is not approved for use on ginger.
The product is known to have been distributed to Albertson's stores and Save Mart stores in northern California by Christopher Ranch of Gilroy, California.
CDPH and the U.S. Food and Drug Administration are tracing the imported ginger from the importer (Modern Trading Inc. in Alhambra, California) to determine the full distribution of the product and to identify other retail stores that may have received the product.
Currently, there are no reports of illness associated with the contaminated ginger.
Consumers who may have purchased this product from Albertson's stores and Save Mart stores in northern California should discard it.
Symptoms of aldicarb poisoning in humans are likely to occur within the first hour following exposure. Ingestion of foods contaminated with aldicarb at low levels can cause flu-like symptoms (nausea, headache, blurred vision) which disappear quickly, usually within 5 or 6 hours. However, at higher levels, ingestion of aldicarb contaminated food can also cause dizziness, salivation, excessive sweating, vomiting, diarrhea, muscle stiffness and twitching, and difficulty in breathing.
Individuals who may have consumed this product and have any of the above symptoms should contact their health care provider immediately
Precautionary Recall Alert Issued for Selected Whole
Wheat Fresh Bread Products
Alert pertains only to products baked at Sara
Lee’s Meridian, Miss. Bakery
FOR IMMEDIATE RELEASE
-- Downers Grove, IL -- July 26, 2007 – Sara Lee Food & Beverage is issuing a
voluntarily and precautionary recall of selected whole wheat bread products
produced at the company's Meridian, Miss. bakery and sold at grocery retailers
in the following areas of the country: the entire states of Mississippi and
Alabama, most of Arkansas, far southeastern Missouri, western Georgia,
southwestern Tennessee, southeastern Louisiana and the panhandle of Florida. The
affected products may contain small pieces of metal.
Sara Lee is working with the U.S. Food and Drug Administration in undertaking this voluntary recall. The affected products are stamped "Best if purchased by" between the dates of July 25, 2007 and August 7, 2007 and include the code "222." This information can be found on the front of the bag. The products were sold in a variety of retail grocery and mass merchant retailers and include:
| Product Description | UPC CODE |
| Colonial Wheat Sandwich 20 oz. | 5040023502 |
| Schnucks Wheat Sandwich 24 oz. | 2412601044 |
| Earthgrains Honey Wheat Berry | 5040072709 |
| Flavorite Wheat Sand. 20 oz. | 4113002364 |
| Foodland Wheat Bread 20 oz. | 4130320964 |
| Golden Bake Wheat Bread 20 oz. | 5040008505 |
| Grissom's Wheat Bread 20 oz. | 5193370220 |
| Grissoms 24oz. Wheat Sand. | 5193370300 |
| IGA 20oz. Wheat | 4127003695 |
| Great Value Split Top Bread 20 oz. | 7874206274 |
| Great Value 24 oz. Wheat Sand | 7874228543 |
| Piggly Wiggly Wheat Bread 20 oz. | 5040000118 |
| Publix Honey Wheat | 4141539095 |
| Publix 100% Stoneground | 4141539190 |
| Publix Wheat 20 oz. | 4141539290 |
| Publix Stone Ground Wheat 20 oz. | 4141539390 |
| Shurfresh Split Top Wheat 20 oz. | 1116144835 |
| EarthGrains 100% Natural Wheat Berry | 5040072748 |
| EarthGrains 100% Natural 7-Grain | 5040072747 |
| EarthGrains 100% Natural Whole Wheat | 5040072746 |
| Sara Lee Delightful Wheat | 7294571706 |
| Sara Lee Delightful 100% Whole Wheat | 7294571589 |
| Sara Lee Delightful 100% Multi-Grain | 7294571588 |
| Sara Lee Hearty & Delicious 100% Whole Wheat with Honey | 7294560152 |
| Sara Lee Hearty & Delicious 100% Whole Wheat | 7294560157 |
| Sara Lee Hearty & Delicious 100% Multi-Grain | 7294560158 |
| Sara Lee Deli Style 100% Whole Wheat | 7294561001 |
Consumers are strongly encouraged to check the packaging of any of these products to determine whether they are included in the recall. Only those products that include the code "222" on the packaging are included in this recall. These products should not be consumed and should be returned to the store where they were purchased for a full refund.
The products are being removed from store shelves, but some may remain in consumer possession. All retail and institutional foodservice customers have been notified, and arrangements for product retrieval have been made.
The recall applies only to products listed above, which are produced in the compan's Meridian, Mississippi bakery. The recall does not apply to any other Sara Lee bread brand, including all products sold under the Soft 'n Smooth label.
Consumers who may have questions or concerns should call Sara Lee's toll-free consumer line at (800) 683-3466. The consumer line is available from 9 a.m. to 4:30 p.m. Central Time.
Castleberry’s Expands Voluntary Recall of Hot Dog Chili Sauce and Canned Meat Products
FOR IMMEDIATE RELEASE --AUGUSTA, Ga. – July 21, 2007 – Castleberry’s Food Company today announced that it is taking extra steps to ensure public safety by voluntarily expanding its recall originally announced on July 18 due to the risk ofbotulinum toxin, a bacterium which can cause botulism.
Botulism can cause the following symptoms: general weakness, dizziness, double-vision and trouble with speaking or swallowing. Difficulty in breathing, weakness of other muscles, abdominal distension and constipation may also be common symptoms. People experiencing these problems should seek immediate medical attention.
The recall originally announced on July 18 affected only 10 products with ‘best by’ dates from APR30 2009 through MAY22 2009. The extended recall now includes the following canned products in the following sizes with all ‘best by’ and code dates:
In addition, the following canned Natural Balance brand pet food products, which Castleberry’s co-packs for Natural Balance, are being recalled. These include:
Consumers should not use these products even if they do not look or smell spoiled. Consumers with these products should dispose of them by double bagging in plastic bags that are tightly closed before being placed in a trash receptacle for non-recyclable trash outside of the home, according to the Food and Drug Administration. Additional instructions for safe disposal can be found at www.cdc.gov/botulism/botulism_faq.htm.
“There is nothing more important to us than the health of those who use our products every day,” said Steve Mavity, SVP Technical Services/Quality Assurance for Castleberry’s. “We are taking every step necessary, and are working hand in hand with health officials around the clock to ensure the safety of consumers.”
Mavity said, “We believe we have isolated the issue to a situation of under-processing on one line of our production facility. As an extra precaution to the recall we announced on Wednesday, we have shut down this line altogether and are recalling all products produced on it.”
Castleberry’s is working with the U.S. Food and Drug Administration (FDA), the United States Department of Agriculture (USDA), and the Centers for Disease Control and Prevention (CDC) to investigate possible contamination of these products.
Castleberry’s was notified by the FDA of two confirmed botulism cases and two potential botulism cases involving individuals who ate Hot Dog Chili Sauce products. No new cases have been reported since the recall was announced on July 18.
There have been no reported illnesses linked to Natural Balance canned pet food, but Castleberry’s recommends that all these products should be discarded. While botulism can affect some pets, dogs and cats are inherently resistant. The disease has only been seen occasionally in dogs and has not been reported in cats. Ferrets are highly susceptible to botulinum toxin. The incubation period can be two hours to two weeks; in most cases, the symptoms appear after 12 to 24 hours. Botulism is characterized by progressive motor paralysis. Typical clinical signs may include muscle paralysis, difficulty breathing, chewing and swallowing, visual disturbances and generalized weakness may also occur. Death usually results from paralysis of the respiratory or cardiac muscles. Pet owners who have used these products and whose pets have these symptoms should contact their veterinarian immediately.
Consumers with any questions should visit Castleberry’s Web site (www.castleberrys.com). A toll-free hotline is also available for consumer questions at 1-800-203-4412 or 1-888-203-8446.
E3: PS3 price cut temporary?
Sony execs indicate discounted $499 PlayStation 3 may disappear from stores in mere months.
Could the welcomed $100 price cut for Sony's PlayStation 3 be temporary? Reported comments from multiple Sony execs in online publications Gamesindustry.biz and Joystiq.com indicate so. The current PlayStation 3 model, which is equipped with a 60 GB hard drive, certainly has received a price cut to $499 and is available at that price right now - but Sony's recent statements indicate that model is no longer in production.
If that's accurate, once those sell out, which could take as little as 1-3 months, the only PlayStation 3 model that's available will be the just-announced premium version. Going on sale in August and equipped with an 80 GB hard drive and racing game Motorstorm, it'll set purchasers back $599. Barring further price cuts, holiday shoppers would potentially still be faced with a $600 PS3, although they'd be getting more for their money.
Karlin Food Products, Inc. Issues Allergy Alert on Undeclared Milk in 'Market Basket Complete Pancake & Waffle Mix'
FOR IMMEDIATE RELEASE --Northfield, Ill.-- July 10, 2007 --- Karlin Food Products, Inc., of Northfield, IL, is recalling its 32-oz (2-lb) cartons of "Market Basket Complete Pancake & Waffle Mix" because it contains undeclared milk. People who have allergies to milk run the risk of serious or life-threatening allergic reaction if they consume this product.
The recalled "Market Basket, Complete Pancake & Waffle Mix" was distributed in the States of Massachusetts and New Hampshire, DeMoulas Super Markets/Market Basket retail stores.
The product comes in a 32-oz (2-lb) red carton with UPC # 49705-14852 on the bottom and an expiration date of 08 29 07 stamped on the top.
The recall was initiated after it was discovered that the product was distributed in packaging that did not reveal the presence of milk. Subsequent investigation indicates the problem was caused by the discovery of dry milk as a sub-ingredient.
Production of the product has been suspended until FDA and the company are certain that the problem has been corrected.
Consumers who have purchased 32-oz (2-lb) cartons of "Market Basket Complete Pancake & Waffle Mix" with this code date are urged to return them to DeMoulas Super Market/Market Basket Stores for a full refund or dispose of them directly. Consumers with questions may contact the company at 1-888-441-8330.
Sheehan to challenge to Pelosi
Six weeks after announcing her departure from the peace movement, Cindy Sheehan said Sunday that she plans to run against House Speaker Nancy Pelosi unless she introduces articles of impeachment against President Bush in the next two weeks.
Sheehan said she will run against the San Francisco Democrat in 2008 as an independent if Pelosi does not seek by July 23 to impeach Bush. That's when Sheehan and her supporters are to arrive in Washington, D.C., after a 13-day caravan and walking tour starting next week from the group's war protest site near Bush's Crawford ranch.
"Democrats and Americans feel betrayed by the Democratic leadership," Sheehan said "We hired them to bring an end to the war. I'm not too far from San Francisco, so it wouldn't be too big of a move for me. I would give her a run for her money."
Wellbaskets.com Is Alerting Customers of the Veggie Booty Voluntary Recall Issued on June 28, 2007 by Robert's American Gourmet
FOR IMMEDIATE RELEASE
--Newtown, Conn. -- July 2, 2003 -- Veggie Booty has been voluntarily recalled by manufacturer Robert's American Gourmet due to possible Salmonella contamination. The recently recalled product, Veggie Booty, was a component of many gift baskets created by www.wellbaskets.com. Any recipients of baskets containing Veggie Booty are instructed to discard the contents of the package and to contact Robert's American Gourmet by phone at 1-800-626-7557 or by e-mail at info@robscape.com for refund or replacement.Bush's move came hours after a federal appeals panel ruled Libby could not delay his prison term in the CIA leak case. That meant Libby was likely to have to report to prison soon and put new pressure on the president, who had been sidestepping calls by Libby's allies to pardon the former chief of staff to Vice President Dick Cheney.
"I respect the jury's verdict," Bush said in a statement. "But I have concluded that the prison sentence given to Mr. Libby is excessive. Therefore, I am commuting the portion of Mr. Libby's sentence that required him to spend thirty months in prison."
Bush left intact a $250,000 fine and two years probation for Libby, and Bush said his action still "leaves in place a harsh punishment for Mr. Libby."
Libby was convicted in March of lying to authorities and obstructing the investigation into the 2003 leak of CIA operative's identity. He was the highest-ranking White House official ordered to prison since the Iran-Contra affair.
Reaction was harsh from Democrats.
"As Independence Day nears, we are reminded that one of the principles our forefathers fought for was equal justice under the law. This commutation completely tramples on that principle," Sen. Charles Schumer, D-N.Y., said through a spokesman.
Libby's supporters celebrated.
Bush's statement made no mention of the term "pardon," and he made clear that he was not willing to wipe away all penalties for Libby.
Attorney William Jeffress said he had spoken to Libby briefly by phone and "I'm happy at least that Scooter will be spared any prison time. ... The prison sentence was imminent but obviously the conviction itself is a heavy blow to Scooter."
Gills Onions Recalls One Lot of Diced Yellow Onions
FOR IMMEDIATE RELEASE -- Oxnard, CA -- June 19, 2007 -- Gills Onions, LLC is recalling diced yellow onions with "Lot #2017-R and a Best if used by 06/16/07." The recall comes after the Washington State Department of Agriculture, during routine testing, detected Listeria monocytogenes in one retail bag of diced yellow onions. Gills Onions is working with both State and Federal officials to determine the cause. At this time there have been no reported illnesses associated with this product.
Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea. Listeria infection can cause miscarriages and stillbirths among pregnant women. Anyone with these symptoms, are encouraged to contact their physician.
The identified lot 2017-R is no longer in production at Gills Onions. As a precautionary measure, both retail and food service diced packs are being recalled. The retail product was labeled with the Trader Joe's brand name and was distributed to stores in Arizona, California, Nevada, New Mexico, Oregon and Washington. The Trader Joe's brand diced onions were packaged in a 10 oz. bag with the Lot 2017-R and a best if used by date of 06/16/07. The lot information for the 10 oz diced retail product can be found printed directly on the back of the package. The foodservice packages were packed in 4/5 lb cartons and labeled under the Gills Onions Brand and the Sysco Natural Brand, both with the Lot 2017-R and the best-if-used by date of 06/16/07 printed directly on the front of the 5 lb bag as well as on the outside carton label. Consumers and Retailers that have this recalled product should either destroy or return to place of purchase.
"Although no illnesses have been reported and only one 10 oz. retail bag of diced onions tested positive, we want to be sure that all diced products associated with the production lot are accounted for," said Nelia Alamo, VP of Marketing. "We are committed to food safety at all levels and we will always put our customers and our consumer first."
Questions can be directed to the company at (800) 348-2255.
FOR IMMEDIATE RELEASE -- Miami, FL -- June 13, 2007 – MainStar America, LLC, Miami, Florida, is initiating a nationwide recall in accordance with the U.S. Food and Drug Administration (FDA) of the toothpaste made in China involving:
| Lot
#20060708 – Item # 160-850 Dr. Cool Toothpaste 120 GR./4 OZ. UPC # 6926597170008 | |
| Lot
#20060708 – Item # 160-852 Superdent Toothpaste 120 GR./4 OZ UPC # 6926597170015 | |
| Lot
#20060708 – Item # 160-860 Everfresh Smile2 Toothpaste 25 GR./ 1 OZ. UPC # 6926597089539 |
This recall has been initiated because the products may contain the poisonous chemical diethylene glycol (DEG). DEG is used in antifreeze and as a solvent, and is a Central Nervous System depressant and potent kidney and liver toxin.
PLEASE RETURN ALL PRODUCTS IMMEDIATELY TO THE STORES WHICH YOU PURCHASED THEM.
CONSUMERS WHO HAVE THE PRODUCTS SHOULD STOP USING/ RETURN / THROW AWAY.
Retailers immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification.
This voluntarily nationwide recall is being made with the knowledge of the U.S. Food and Drug Administration. No injuries or illnesses have been reported to date in connection with this problem.
Adverse Reactions or quality problems experience with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or fax.
Online:
www.fda.gov/medwatch/report.htm
Regular Mail: use postage-paid FDA form 3500 available at
www.fda.gov/MedWatch/getforms.htm
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
Fax: 1-800-FDA-0178
In a statement on her Web site, Clarkson said: "In the craziness of the music business, performing is what I look forward to doing the most, so it really is disappointing for me to have to tell you that I won't be coming out to tour this summer. The fact is that touring is just too much too soon.
"But I promise you that we're going to get back out there as soon as is humanly possible to give you a show that will be even better," she added
Ruth Graham, who surrendered dreams of missionary work in Tibet to marry a suitor who became the world's most renowned evangelist, died Thursday. She was 87.
Graham died at 5:05 p.m. at her home at Little Piney Cove, surrounded by her husband and all their five children, said a statement released by Larry Ross, Billy Graham's spokesman
MS USA Trading, Inc. Recalls "Colgate Toothpaste" Because of Possible Health Risk
FOR IMMEDIATE RELEASE -- June 13, 2007 -- MS USA Trading, Inc. of North Bergen, NJ, is recalling all lots of 5 ounce tubes of Colgate, because it has the potential to be contaminated with diethylene glycol (DEG) chemical found in anti-freeze. MS USA Trading is concerned about potential risks from chronic exposure to DEG and exposure to DEG in certain populations, such as children and individuals with kidney or liver disease.
Colgate was distributed in NJ, NY, PA and MD in discount retail stores.
The product comes in a 5 ounce (100ml), made in South Africa is printed on the box. The recall includes the following brands: Regular, Gel, Triple and Herbal.
No illnesses have been reported to date in connection with this problem.
The potential for contamination was noted after routine testing by the FDA revealed the presence of diethylene glycol(DEG) in some 5 ounce of "Colgate".
Production of the product has been suspended while the company continues their investigation as to the source of the problem.
Consumers who have purchased 5 ounce of "Colgate Toothpaste" in Regular, Gel, Triple and Herbal are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-201-869-0010.
Counterfeit Colgate Toothpaste Found
NEW YORK, June 14, 2007 /PRNewswire-FirstCall/ -- The Colgate-Palmolive Company today warned that counterfeit toothpaste falsely packaged as "Colgate" has been found in several dollar-type discount stores in four states: New York, New Jersey, Pennsylvania and Maryland. There are indications that this product does not contain fluoride and may contain Diethylene Glycol. The Company stated that it does not use, nor has ever used, Diethylene Glycol as an ingredient in Colgate toothpaste anywhere in the world.
The counterfeit toothpaste can be easily recognized because it is labelled as "Manufactured in South Africa." Colgate does not import toothpaste into the United States from South Africa. In addition, the counterfeit packages examined so far have several misspellings including: "isclinically", "SOUTH AFRLCA" and "South African Dental Assoxiation."
Counterfeit toothpaste is not manufactured or distributed by Colgate and has no connection with the Company whatsoever. Colgate is working closely with the US FDA to help to identify those responsible for the counterfeit product.
Consumers who suspect they may have purchased counterfeit product, can call Colgate's toll-free number at 1 800 468 6502.
About Colgate-Palmolive: Colgate-Palmolive is a leading global consumer products company, tightly focused on Oral Care, Personal Care, Home Care and Pet Nutrition. Colgate sells its products in over 200 countries and territories around the world under such internationally recognized brand names as Colgate, Palmolive, Mennen, Softsoap, Irish Spring, Protex, Sorriso, Kolynos, Elmex, Tom's of Maine, Ajax, Axion, Soupline, and Suavitel, as well as Hill's Science Diet and Hill's Prescription Diet. For more information about Colgate's global business, visit the Company's web site at http://www.colgate.com/.
This press release may contain forward-looking statements. Such statements may relate, for example, to sales or volume growth, profit growth, earnings growth, financial goals, cost-reduction plans, estimated charges and savings associated with the 2004 Restructuring Program and new product introductions. These statements are made on the basis of our views and assumptions as of this time and we undertake no obligation to update these statements. We caution investors that any such forward-looking statements are not guarantees of future performance and that actual events or results may differ materially from those statements. Investors should consult the Company's filings with the Securities and Exchange Commission (including the information set forth under the caption "Risk Factors" in the Company's Form 10-K for the year ended December 31, 2006) for information about factors that could cause such differences. Copies of these filings may be obtained upon request from the Company's Investor Relations Department or the Company's web site at http://www.colgate.com/.
Source: Colgate-Palmolive
Web site: http://www.colgate.com/
WholeSoy & Co. Expands National Allergy Alert on Undeclared Dairy in Blueberry and Mixed Berry Yogurt
FOR IMMEDIATE RELEASE -- San Francisco, CA -- June 12, 2007 -- WholeSoy & Co. of San Francisco, CA is expanding their allergy alert to include an additional batch of WholeSoy & Co. Blueberry yogurt and two additional batches of WholeSoy & Co. Mixed Berry yogurt. Previously, only one batch of Blueberry yogurt was recalled.
WholeSoy & Co. is recalling 71,508 cups of WholeSoy & Co. Blueberry yogurt and 17,112 cups of WholeSoy & Co. Mixed Berry yogurt because they may contain undeclared dairy. People who have an allergy or severe sensitivity to dairy run the risk of serious or life-threatening allergic reaction if they consume these products.
The yogurt was distributed nationwide through retailers.
The affected batches of Blueberry yogurt have "best by" date of June 22 and "best by" date of June 29. The UPC code is 664372600086. The containers are 6oz plastic yogurt cups.
The affected batches of Mixed Berry yogurt have "best by" date of June 22 and "best by" date of June 29. The UPC code is 664372600222. The containers are 6oz plastic yogurt cups.
The recall was initiated after allergy tests confirmed the presence of dairy in samples sent for testing after two customers reported allergic reactions. Subsequent tests indicate the source of the dairy to be a batch of blueberry fruit used in both of these flavors. No other flavors of WholeSoy & Co. soy yogurts contain this ingredient.
Consumers who have purchased WholeSoy & Co. Blueberry yogurt or WholeSoy & Co. Mixed Berry yogurt with "best by" date June 22 or June 29 are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at 1-877-569-6376.
FOR IMMEDIATE RELEASE -- Hallandale, FL -- June 8, 2007 -- Gold City Enterprise LLC, Hallandale, Florida, is initiating a nationwide recall in accordance with the U.S. Food and Drug Administration (FDA) of the toothpaste made in China involving:
| Lot #777A – SHIR FRESH MINT FLUORIDE 9 oz UPC # 859750001023 | |
| Lot #777B – SHIR FRESH MINT FLUORIDE PASTE 9 oz UPC # 859750001016 | |
| Lot #777C – SHIR FRESH MINT FLUORIDE 9 oz UPC # 859750001023 | |
| Lot #777D – SHIR FRESH MINT FLUORIDE PASTE 9 oz UPC # 859750001016 | |
| Lot #2471A- SHIR FRESH ICE SHIR MINT FLUORIDE TOOTHPASTE 6.4 oz., UPC # 859750001092 | |
| Lot #2471B- SHIR FRESH COOL SHIR MINT FLUORIDE TOOTHPASTE 6.4 oz. UPC # 859750001115 |
This recall has been initiated because the products may contain the poisonous chemical diethylene glycol (DEG). DEG is used in antifreeze and as a solvent, and is a Central Nervous System depressant and potent kidney and liver toxin.
PLEASE RETURN ALL PRODUCTS IMMEDIATELY TO THE STORES WHICH YOU PURCHASED THEM.
CONSUMERS WHO HAVE THE PRODUCTS SHOULD STOP USING/ RETURN / THROW AWAY.
Retailers immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification.
This voluntarily nationwide recall is being made with the knowledge of the U.S. Food and Drug Administration. No injuries or illnesses have been reported to date in connection with this problem.
Adverse Reactions or quality problems experience with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or fax.
Online:
www.fda.gov/medwatch/report.htm
Regular Mail: use postage-paid FDA form 3500 available at
www.fda.gov/MedWatch/getforms.htm
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
Fax: 1-800-FDA-0178
Shirley Jones Responds to "Bitch" Remark from Florence Henderson
| Crest Toothpaste Safe |
Crest Toothpaste Sold In U.S. Is Manufactured In North America CINCINNATI, June 2 /PRNewswire-FirstCall/ -- The Procter & Gamble Company's Crest toothpaste brand is not affected by the FDA import and health alert. Crest does not import toothpaste manufactured in China to the U.S. All Crest toothpaste sold in the U.S. is manufactured in North America, the majority at our facility in Greensboro, NC. Crest toothpaste sold in China is not manufactured by nor associated with any of the companies under investigation for exporting tainted toothpaste. All Crest products are safe for use when used as directed. The products and their ingredients undergo rigorous scientific evaluations before going to market. They are manufactured and packaged in accordance with the FDA's good manufacturing practices. Crest also continually monitors the safety and use of our products once in market. Crest products do not contain diethylene glycol. Glycerin used in Crest products is manufactured in the United States. Glycerin included in Crest products meets rigid United States Pharmacopeia (USP) standards requiring two independent tests to ensure diethylene glycol is not present. In addition to meeting USP regulations, Crest retests the glycerin internally to confirm that it meets these standards. About Procter & Gamble [NYSE: PG] Three billion times a day, P&G brands touch the lives of people around the world. The company has one of the strongest portfolios of trusted, quality, leadership brands, including Pampers(R), Tide(R), Ariel(R), Always(R), Whisper(R), Pantene(R), Mach3(R), Bounty(R), Dawn(R), Pringles(R), Folgers(R), Charmin(R), Downy(R), Lenor(R), Iams(R), Crest(R), Oral-B(R), Actonel(R), Duracell(R), Olay(R), Head & Shoulders(R), Wella, Gillette(R), and Braun. The P&G community consists of over 135,000 employees working in over 80 countries worldwide. Please visit http://www.pg.com for the latest news and in-depth information about P&G and its brands. |
Out of caution, the Food and Drug Administration said, people should throw away toothpaste with labeling that states it was made in China. FDA is concerned that these products may contain diethylene glycol.
The agency is not aware of any reports in the United States of poisoning from toothpaste, but it did find the antifreeze ingredient in a shipment at the U.S. border and at two retail stores: a Dollar Plus store in Miami and a Todo A Peso store in Puerto Rico.
Officials said they are primarily concerned about toothpaste sold at bargain retail outlets. The ingredient in question, called DEG, is used as a lower-cost sweetener and thickening agent. The highest concentration of the chemical found in toothpaste so far was between 3-4 percent.
"It does not belong in toothpaste even in small concentrations," said the FDA's Deborah M. Autor.
The FDA increased its scrutiny of toothpaste made in China because of reports of contamination in several countries, including Panama.
The agency is particularly concerned about chronic exposure to DEG in children and in people with kidney or liver disease.
Agency officials said they had no estimate of how many tubes of tainted toothpaste might have made it into the U.S.
"Our concern today is potentially about all toothpaste that comes in from China," Autor said. "Our estimate is that China makes up about $3.3 million of the $2 billion U.S. toothpaste market."
The agency also issued an import alert for all dental products containing DEG. The alert means that toothpaste from China will be stopped at the border, she said.
The alert states that DEG has been improperly used in a variety of sedatives, syrups and cough medicines worldwide. Most recently, a cough syrup containing DEG resulted in more than 40 deaths in Panama last September.
The alert says the agency found DEG in three products manufactured by Goldcredit International Trading in China. The products are Cooldent Fluoride, Cooldent Spearmint and Cooldent ICE. Analysis of the products revealed that they contained between 3 percent and 4 percent DEG.
The agency also found the chemical in one product manufactured by Suzhou City Jinmao Daily Chemical Co. in China. Analysis of that product, Shir Fresh Mint Fluoride Paste, found that it contained about 1 percent DEG.
___
On the Net:
Import Alert from FDA: http://www.fda.gov/ora/fiars/ora
Tembec and Uniscope Voluntary Recall Feed Ingredients
FDA Asks Feed Manufacturers to Avoid Ingredients Containing Melamine
The U.S. Food and Drug Administration (FDA) is alerting livestock and fish/shrimp feed manufacturers about a voluntary recall of products used in feed production because several have been found to contain melamine and related compounds.
The feed ingredients were made by Tembec BTLSR Inc. of Toledo, Ohio and Uniscope, Inc. of Johnstown, Colo.
Tembec, a contract manufacturer for Uniscope, makes AquaBond and Aqua-Tec II, which it distributes for Uniscope. Uniscope makes Xtra-Bond using ingredients supplied by Tembec. All of the products are binding agents that are used to make pelleted feed for cattle, sheep, and goats, or fish and shrimp.
The companies have confirmed that Tembec added melamine as part of the formulation of the products to improve the binding properties of pelleted feed. Melamine is not approved as an additive for animal or fish/shrimp feed.
The companies have stopped adding melamine to the feed products.
Based on the levels of melamine and related compounds in the initial ingredients, FDA estimated the probable level of melamine and related compounds in livestock feed as less than 50 parts per million (ppm) based on the recommended mix rate of two to four pounds of binding agent per ton of livestock feed. The estimated levels in fish and shrimp feed are less than 233 ppm and 465 ppm, respectively, of melamine and related compounds. The estimated levels of melamine and related compounds vary in the livestock feed and the fish and shrimp feed because of differing levels of melamine in the binding agents used for each type of feed.
FDA advises feed manufacturers and others who mix their own feed not to use these products, and to contact the manufacturers. FDA advises feed manufacturers to recall finished feed that is made from AquaBond or Aqua-Tec II due to the estimated levels of melamine and related compounds in the finished products. FDA believes that no recall is warranted of the finished feed made from Xtra-Bond based on the estimated levels of melamine and related compounds in the finished product and based on currently available data and information.
The estimated melamine levels in feed made with these binding agents are similar to the levels discussed in the interim safety/risk assessment of melamine and related compounds made available by FDA earlier this month. In that assessment, federal scientists determined that, based on currently available data and information, the consumption of pork, chicken, domestic fish, and eggs from animals inadvertently fed animal feed contaminated with melamine and its analogues is very unlikely to pose a human health risk.
The interim safety/risk assessment concludes that in the most extreme risk assessment scenario, when scientists assumed that all the solid food a person consumes in an entire day contained melamine and the melamine compound cyanuric acid in equal amounts, the potential exposure is about 250 times lower than the dose considered safe. This is a large safety margin. Translated to consumption levels, this means that a person weighing 132 pounds would have to eat more than 800 pounds per day of food containing melamine and its compounds to approach a level of consumption that would cause a health concern.
FDA is encouraging domestic feed suppliers to be vigilant in quality control in their supply chain and to monitor for any improper additives, including melamine and its analogs.
The Tembec and Uniscope products also reportedly contain a urea formaldehyde resin-type ingredient, a raw ingredient used to make the binding agent in these products. FDA is investigating this use of the urea formaldehyde resin-type ingredient in the Tembec and Uniscope products, and will take appropriate regulatory action if warranted.
Abbott Announces Voluntary Nationwide Recall of Three Lots of Two-Ounce Bottles of Similac Special Care 24 Cal / fl. oz. Ready-to-Feed (RTF) Premature Infant Formula with Iron
Contact:
Consumer Hotline
888-899-9182
FOR IMMEDIATE RELEASE -- Columbus, OH -- May 25, 2007 -- Abbott's Ross Products Division today announced a voluntary nationwide recall of three lots of two-ounce bottles of Similac Special Care 24 Cal / fl. oz. Ready-to-Feed (RTF) Premature Infant Formula with Iron, a highly specialized liquid ready-to-feed formula used only for premature infants after discharge from the hospital. This product is sold in eight unit cartons of two-ounce plastic bottles in the United States, and is primarily sold through pharmacies at the direction of a health care professional. It is not commonly available on retail store shelves.
Abbott is voluntarily recalling these three lots because they do not contain as much iron as indicated on the label. No serious medical complaints have been reported.
Premature infants fed this formula for more than a month after discharge could have an increased risk of developing anemia due to insufficient iron intake. If parents have any concerns about their baby's health, they should contact their baby's doctor or health care professional.
The recall is limited to stock code number 59582 with lot numbers 46815D5, 47847D5 or 52023D5 printed on the outside carton and case and the lot numbers 44427X8, 4427X81 or 50005X8 printed on the bottom of the bottles. No other liquid or powdered Similac infant formulas are affected.
The three lots of infant formula were distributed in the United States between November 2006 and May 2007. Consumers who purchased Similac Special Care 24 Cal / fl. oz. RTF Premature Infant Formula with Iron from any of the specific lots mentioned above should contact Abbott's Ross Products Division at 1-888-899-9182. Ross will replace product from these lots free of charge.
Similac Special Care 24 Cal / fl. oz. RTF Premature Infant Formula is a highly specialized formula used by premature infants for a limited amount of time after discharge from the hospital. The impacted product is not used in hospitals.
Abbott is working with the U.S. Food and Drug Administration and its distribution partners to execute this recall.
Advanced Medical Optics Voluntarily Recalls Complete MoisturePlus Contact Lens Solution
The U.S. Food and Drug Administration is alerting health care professionals and their patients who wear soft contact lenses about a voluntary recall of Complete MoisturePlus Multi Purpose Solution manufactured by Advanced Medical Optics of Santa Ana, Ca.
The company is taking this action as a precaution because of reports of a rare, but serious, eye infection, Acanthamoeba keratitis, caused by a parasite. The link between the solution and the infection was identified as a result of an investigation by the Centers for Disease Control and Prevention (CDC).
Consumers who wear soft contact lenses should stop using the solution, discard all partially-used or unopened bottles and replace their lenses and storage container.
"We believe the company acted responsibly in taking this voluntary action and support their decision to be proactive in the interest of public health," said Daniel Schultz, M.D., director of FDA's Center for Devices and Radiological Health. "FDA and CDC are working closely with the company to collect additional information and we will continue to alert consumers and advise them as more information becomes available."
Acanthamoeba keratitis may lead to vision loss with some patients requiring a corneal transplant. The infection primarily affects otherwise healthy people who wear contact lenses.
Consumers should ask their doctor about choosing an appropriate alternative cleaning/disinfecting product and seek immediate treatment if they have symptoms of eye infection as early diagnosis is important for effective treatment. The symptoms of Acanthamoeba keratitis can be very similar to those of other more common eye infections and may include eye pain or redness, blurred vision, light sensitivity, sensation of something in the eye or excessive tearing but Acanthamoeba is more difficult to treat.
It is estimated that Acanthamoeba keratitis infections occur in approximately 2 out of every 1 million contact lens users in the United States each year. However, in a multi-state investigation to evaluate a recent increase in Acanthamoeba keratitis cases, CDC determined that the risk of developing AK was at least seven times greater for those consumers who used Complete MoisturePlus solution versus those who did not. Additional information regarding the CDC results is available at the CDC website http://www.cdc.gov/mmwr.
"The ongoing CDC investigation is a collaborative effort," said Michael Beach, M.D., a Division of Parasitic Diseases team leader with CDC. "We are working with FDA, state, territory, university, and clinical partners in an effort to further understand whether usage or contamination of this solution led to these Acanthamoeba infections."
All contact lens users should closely adhere to the following measures to help prevent eye infections:
Schedule regular eye exams with your eye care professional
Wear and replace contact lenses according to the schedule prescribed by your eye care professional.
Store lenses in a proper storage case.
FDA and CDC want to gather information related to Acanthamoeba keratitis in contact lens users. Report adverse events related to these products to MedWatch, the FDA's voluntary reporting program: www.fda.gov/medwatch/report.htm; Phone: (800) 332-1088; Fax: (800) 332-0178; Mail: MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD, 20852-9787.
Consumers who believe they are in possession of the recalled product may call the company at 1-888-899-9183.
Additional information about Acanthamoeba infection is available from the CDC website at http://www.cdc.gov/ncidod/dpd/parasites/acanthamoeba/index.htm
FDA Warning on Mislabeled Monkfish
Fish Believed to be Puffer Fish; Contains Deadly Toxin
The Food and Drug Administration (FDA) is warning consumers not to buy or eat imported fish labeled as monkfish, which actually may be puffer fish, containing a potentially deadly toxin called tetrodotoxin. Eating puffer fish that contain this potent toxin can result in serious illness or death.
Tetrodotoxin is not destroyed by common food preparation or storage, such as cooking or freezing. Monkfish do not contain tetrodotoxin.
The product was imported and distributed by Hong Chang Corp., Santa Fe Springs, Calif.
Consumers concerned that they may have purchased this fish should contact their retailer and ask if the product was received from Hong Chang Corp.
The product should not be eaten, it should be thrown away. Care should be exercised in handling the fish, as the tetrodotoxin may be present on the skin and flesh of the fish. Consumers should wash hands thoroughly after handling the fish.
Two people in the Chicago area became ill after consuming homemade soup containing the fish. One was hospitalized due to severe illness.
FDA's analysis of the fish confirmed the presence of potentially life-threatening levels of tetrodotoxin.
Initial symptoms of tetrodotoxin poisoning occur 30 minutes to several hours after food containing the toxin is consumed. Tetrotoxin poisoning is characterized initially by tingling of the lips and tongue. Tingling of the face and extremities and numbness follow. Subsequent symptoms may include headache, balance problems, excessive salivation, nausea, vomiting, diarrhea and abdominal pain. Consumers experiencing these symptoms should seek immediate medical care and are encouraged to report their illness to local health authorities. In severe cases, muscles can become paralyzed, and death may follow from respiratory muscle paralysis.
A total of 282 22-pound boxes labeled as monkfish were distributed to wholesalers in Illinois, California and Hawaii beginning in September 2006. These fish were then sold to restaurants or sold in stores. In one instance, the retailer labeled the fish as "bok," the Korean name for puffer fish.
The white 22-pound boxes were labeled in black ink. One box panel is labeled as: "FROZEN MONKFISH GUTTED AND HEAD-OFF" and "PRODUCT OF CHINA." A second panel bears nutritional facts and the following: "Ingredients: Monk fish; Imported by: Hong Chang Corp, Santa Fe Springs, CA 90670; Product of China (P.R.C.)." A third panel has a checkbox indicating the size as either "0.5-1" or "1-2" and shows the net weight as 22 pounds. There are no manufacturing codes on the box. The fish in the box are individually wrapped in plastic bags with no labeling.
FDA allows puffer fish to be imported into the United States only under strict provisions that minimize the risk of the toxin being present in the fish. The recalled fish were not imported in compliance with those restrictions. FDA is examining all entries from the Chinese supplier and will take additional action, if warranted.
Whole Foods Market Issues Nationwide Recall of 365 Organic Everyday Value Sesame Tahini
FOR IMMEDIATE RELEASE -- Austin, TX -- May 22, 2007 - Whole Foods Market is voluntarily recalling 365 Organic Everyday Value Sesame Tahini 16-oz, with a Best By Date of 10/02/07 or earlier because it has the potential to be contaminated with Salmonella.
Food contaminated with Salmonella may not look or smell spoiled. Consumption of food contaminated with this bacteria may cause salmonellosis, a foodborne illness. In young children, the elderly and people with weakened immune systems, salmonellosis may cause serious and sometimes deadly infections. In otherwise healthy people, salmonellosis may cause short-term symptoms such as high fever, severe headache, vomiting, nausea, abdominal pain and diarrhea. Long-term complications may include severe arthritis.
365 Organic Everyday Value Sesame Tahini was distributed nationally through Whole Foods Market retail stores. The product comes in a 16-oz glass jar with the UPC number 0009948240599. The Best By Date is located on the top of the lid of the jar, any Best By Date of 10/02/07 or earlier is being recalled. No confirmed illnesses have been reported to date.
Potential salmonella contamination was brought to the attention of Whole Foods Market by the product's manufacturer. As a result, the company is voluntarily recalling this product as a precautionary measure and has put additional safety measures in place. No other Whole Foods Market Private Label products have been affected by this recall.
Consumers who have purchased 365 Organic Everyday Value Sesame Tahini can return it to Whole Foods Market for a full refund. Questions may be directed to the Company by calling (512) 477-5566 x20656 or via email at privatelabel.customerservice@wholefoods.com.
The 280-142 vote sent the bill to the Senate for final passage, expected later Thursday night
NBTY, Inc. Conducts Nationwide Recall of Shark Cartilage Capsules Because of Possible Health Risk
FOR IMMEDIATE RELEASE -- May 16, 2007 -- NBTY, Inc. of Bohemia, NY, is recalling 3 lots of Shark Cartilage Capsules manufactured in 2004 because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
The Shark Cartilage Capsules were distributed to consumers through mail orders, internet orders, and retail stores throughout the United States.
The Shark Cartilage Capsules were packaged for various NBTY divisions and sold under the following labels, lots, and codes:
No illnesses have been reported to date.
This issue was discovered during routine testing of the product. Testing on additional batches of Shark Cartilage did not show any evidence of contamination.
Customers may return product back to the place of purchase for a full refund. Customers may also contact the company with questions and to obtain information on how to return the product at 1-800-217-7668.
XM Radio Suspends Opie & Anthony
- XM Radio announced today that the company has
suspended Gregg "Opie" Hughes and Anthony Cumia, hosts of "The Opie & Anthony
Show" and ceased broadcast of the show for 30 days, effective immediately.
XM Radio deplored the comments aired on "The Opie &
Anthony Show" last week. At the time, the company strongly expressed its views
to Opie and Anthony, and they issued an immediate apology.
Comments made by Opie and Anthony on yesterday's
broadcast put into question whether they appreciate the seriousness of the
matter. The management of XM Radio decided to suspend Opie and Anthony to make
clear that our on-air talent must take seriously the responsibility that
creative freedom requires of them.
As a company, XM provides customers with tools to
control what they listen to on XM. "The Opie & Anthony Show" appears on one of
XM's explicit language channels (XL). Whenever a radio is tuned to an explicit
language channel, the letters "XL" continuously appear on the screen. XM
frequently mentions on its explicit language channels that the content may be
inappropriate for certain listeners and tells how to "block" channels that
feature this type of content. Channel blocking is available through xmradio.com
or by calling 1-800-XMRADIO.
About XM Satellite Radio
XM (NASDAQ:XMSR)
is America's number one satellite radio company with more than 8 million
subscribers. Broadcasting live daily from studios in Washington, DC, New York
City, Chicago, the Country Music Hall of Fame in Nashville, Toronto and
Montreal, XM's 2007 lineup includes more than 170 digital channels of choice
from coast to coast: commercial-free music, premier sports, news, talk radio,
comedy, children's and entertainment programming; and the most advanced traffic
and weather information.
XM, the leader in satellite-delivered entertainment and data services for the automobile market through partnerships with General Motors, Honda, Hyundai, Nissan, Porsche, Subaru, Suzuki and Toyota, is available in 140 different vehicle models for 2007. XM's industry-leading products are available at consumer electronics retailers nationwide. For more information about XM hardware, programming and partnerships, please visit http://www.xmradio.com/.
Cerberus Takes Over Majority Interest In Chrysler Group and Related Financial Services Business for $7.4 Billion From DaimlerChrysler
- Affiliate of Cerberus to acquire 80.1% equity interest in new company Chrysler Holding LLC; DaimlerChrysler AG to retain 19.9%
- Obligations for pensions and healthcare costs to be retained by Chrysler companies
- Transaction expected to result in net cash outflow of $0.65 billion for DaimlerChrysler
- DaimlerChrysler's net profit according to IFRS in 2007 to be reduced in a range of $4.1-5.4 billion
- Equity ratio of DaimlerChrysler's industrial business is expected to be over 40% by the beginning of 2008
- Extraordinary Shareholders' Meeting to decide on change of name to Daimler AG
- DaimlerChrysler CEO Dieter Zetsche on the realignment of DaimlerChrysler AG: "We will be the leading manufacturer of premium vehicles and a provider of premium services in every market segment we serve worldwide."
- UAW President Ron Gettelfinger: "The transaction with Cerberus is in the best interests of our UAW members, the Chrysler Group and Daimler."
- Cerberus Capital Management Chairman John Snow: "Cerberus believes in the inherent strength of U.S. manufacturing and of the U.S. auto industry. Most importantly, we believe in Chrysler."
STUTTGART, Germany, May 14 /PRNewswire-FirstCall/ --
The Board of Management of DaimlerChrysler AG (stock-exchange abbreviation DCX)
has today decided, subject to the approval of the Supervisory Board and the
relevant authorities, on the future concept for the Chrysler Group and the
realignment of DaimlerChrysler AG. Completion of the transaction is subject to
the satisfaction of customary closing conditions, including the receipt of
regulatory approvals and Cerberus financing arrangements.
Details will be explained at a press conference in
Stuttgart today at 2 p.m. CET/8 a.m. EDT.
Structure of the transaction
-- An affiliate of private equity firm Cerberus Capital Management, L.P.,
New York, will make a capital contribution of $7.4 billion in return
for an 80.1% equity interest in the future new company, Chrysler
Holding LLC. DaimlerChrysler will hold a 19.9% equity interest in the
new company. Chrysler Holding LLC will hold 100% each of the future
Chrysler Corporation LLC, which produces and sells Chrysler, Dodge and
Jeep(R) vehicles, and the future Chrysler Financial Services LLC, which
provides financial services for these vehicles in the NAFTA region.
-- Of the total capital contribution of $7.4 billion, $5.0 billion will
flow into the industrial business (Chrysler Corporation LLC) and $1.05
billion will flow into the financial services business in order to
strengthen the equity base of both businesses. DaimlerChrysler will
receive the balance of $ 1.35 billion. In addition, DaimlerChrysler
will grant a loan of $0.4 billion to Chrysler Corporation LLC.
-- According to the agreement, upon the closing of the transaction,
DaimlerChrysler will transfer the industrial business of the Chrysler
Group completely free of debt. Due to the Chrysler Group's anticipated
negative cash flow until closing in connection with its restructuring
plan, the transaction will give rise to a cash outflow of $1.6 billion
for DaimlerChrysler. The overall net cash outflow resulting from the
transaction will therefore be $0.65 billion. In addition,
DaimlerChrysler will have to discharge long-term liabilities of the
Chrysler Group in connection with the transaction. This will result in
prepayment compensation of approximately $878 million, to be borne by
DaimlerChrysler. The usual transaction costs will also be incurred.
-- The Chrysler Group's financial obligations for pension and healthcare
benefits towards its employees and the employees of the financial
services business related to the Chrysler Group will be retained by the
Chrysler companies. The pension plans are significantly over-funded at
present.
Effects on key figures
The transaction will have the following effects on DaimlerChrysler AG:
-- In total, current estimates indicate that net profit according to IFRS
in 2007 will be reduced by $4.1-5.4 billion.
-- Due to the deconsolidation of the Chrysler companies and the resulting
reduction in the balance-sheet total, the equity ratio of
DaimlerChrysler's industrial business is expected to increase to more
than 40% by the beginning of 2008.
-- There will be no changes relating to the bonds issued and guaranteed by
DaimlerChrysler AG. In the financial services business for the
Chrysler, Jeep (R) and Dodge brands, Cerberus will take over the
financing previously provided by DaimlerChrysler AG.
-- The 19.9% equity interest held by DaimlerChrysler AG in the new company
Chrysler Holding LLC will be included after closing at equity in the
Van, Bus, Others segment.
-- The closing of the transaction is expected to take place in the third
quarter of 2007.
Dr. Dieter Zetsche, Chairman of the Board of Management
of DaimlerChrysler AG and Head of the Mercedes Car Group: "We're confident that
we've found the solution that will create the greatest overall value - both for
Daimler and Chrysler. With this transaction, we have created the right
conditions for a new start for Chrysler and Daimler."
Ron Gettelfinger, President of the United Autoworkers (UAW):
"The transaction with Cerberus is in the best interests of our UAW members, the
Chrysler Group and Daimler. We are pleased that this decision has been made,
because our members and the management can now focus entirely on the development
and manufacture of quality products for the future of the Chrysler Group."
John W. Snow, Chairman of Cerberus Capital Management,
L.P.: "We welcome Chrysler into the Cerberus family of companies and believe
Cerberus will be a good home for Chrysler. Cerberus believes in the inherent
strength of U.S. manufacturing and of the U.S. auto industry. Most importantly,
we believe in Chrysler."
Snow continued: "We would like to thank DaimlerChrysler
for their good stewardship of this American icon over the last decade. We are
aware that Chrysler faces significant challenges, but we are confident that they
can and will be overcome. A private investment firm like Cerberus will provide
management with the opportunity to focus on their long-term plans rather than
the pressures of short-term earnings expectations."
Business progress
In nearly ten years as DaimlerChrysler, a lot has been
done to move the businesses forward. The synergies possible between
Mercedes-Benz and Chrysler have been fully utilized. Additional potential for
collaboration is limited between two businesses operating in such different
market segments. The strong volatility and pressure on margins in the Chrysler
Group's North American core market have an increasingly negative impact on
DaimlerChrysler's overall profitability and share-price development.
The Chrysler Group has made substantial progress in
recent years. For example, production hours per vehicle have fallen from 48
hours in 2001 to just over 30 at present. Quality has improved by more than 40%
over the past six years. Since 2002, more than $10 billion has been invested in
new production facilities and technologies. And with 34 new models since 2001,
Chrysler has one of the youngest product lines in the industry.
Zetsche: "As a result, Chrysler today is structurally
more sound than its North American based competitors. And with Cerberus as a
partner, Chrysler will have the best chances of utilizing its full potential."
Ongoing collaboration
Existing projects with the Mercedes Car Group will be
continued, for example in the development of conventional and alternative drive
systems, purchasing, and sales and financial services outside the NAFTA region.
Furthermore, a Joint Automotive Council will be established in which
representatives of both sides will assess and decide on the potential of new and
current projects. The Council will be led by board-level members from each
company.
Zetsche: "We very much look forward to our continued
cooperation as business partners, as we want to continue to reap the mutual
benefits of working together. That's one of the reasons why we're retaining a
19.9% equity position in Chrysler."
New Daimler AG
Due to the new corporate structure, the name of
DaimlerChrysler AG is to be changed to Daimler AG. A decision on this is to be
taken by the shareholders at an Extraordinary Shareholders' Meeting probably in
fall 2007.
The Board of Management of the new company will be
reduced to six members. Tom LaSorda, Eric Ridenour and Tom Sidlik will leave the
Board of Management with the Group's sincere thanks.
There will no longer be a separate board position for
procurement in the new Daimler AG. In the future, all procurement activities
will be directly coordinated between the divisions. Within the Board of
Management, Bodo Uebber will additionally assume overall responsibility for
procurement.
The leadership teams of the Mercedes Car Group, the
Truck Group and Financial Services will remain unchanged, as will the teams in
the vans and buses businesses.
Zetsche: "We've done our homework in our corporate
functions and in all of our divisions. As a result of our strategic review, we
have a well-defined roadmap to lead us into a good future."
The Mercedes Car Group will generate a return on sales
of at least 7% this year, with higher rates to follow in the coming years.
The Truck Group will achieve an average return on sales
of 7% over the cycle as of 2008. This represents a return on net assets of
approximately 30%.
DaimlerChrysler is also a world leader and
profitability benchmark for buses. And in the vans business, which is performing
very well, the new Sprinter will continue the success story of its predecessor.
The Financial Services division aims to earn a return
on equity of more than 14%.
Growth perspectives
Zetsche: "We have a strong starting position. We have
an above-average financial power. And our future prospects are promising." The
Group has defined the following main areas for continued growth:
-- Further expansion in the core business, which means in the traditional
segments that are the most profitable and have the highest growth
rates, as well as exploiting new market opportunities on a regional
basis.
-- Continued development of innovative, customer-oriented and tailor-made
services and activities, pursuing opportunities both up and down the
value chain.
-- Strengthening leadership in sustainable, responsible and
environmentally friendly technologies.
By focusing on these three areas, Daimler's full
potential is to be exploited and enterprise value is to be increased further
through profitable and sustainable growth. Daimler intends to do this on its
own, while continuing to benefit from opportunities of scale with Chrysler.
Zetsche on Daimler's goals: "We will be the leading
manufacturer of premium products and a provider of premium services in every
market segment we serve worldwide. And we will pursue our commitment to
excellence based on a common culture, a great heritage of innovation and
pioneering achievements and - with Mercedes-Benz - the strongest automotive
brand in the world.
Cerberus Capital Management, L.P., New York, is one of
the largest private investment firms in the world, with approximately $23.5
billion under management in funds and accounts. Founded in 1992, Cerberus
currently has significant investments in more than 50 companies that, in
aggregate, generate more than $60 billion in annual revenues worldwide.
For the reader's convenience, the financial information
has been translated from euros into US dollars at an assumed rate of EUR1 =
$1.35. The convenience translation does not mean that the euro amounts actually
represent the corresponding dollar amounts stated or that they could be
converted into dollars at the assumed rate.
This document contains forward-looking statements that
reflect our current views about future events, including, among others, the
pendency and consummation of the transaction with Cerberus Capital Management,
L.P. regarding Chrysler Group. The words "anticipate," "assume," "believe,"
"estimate," "expect," "intend," "may," "plan," "project," "should" and similar
expressions are used to identify forward-looking statements. These statements
are subject to many risks and uncertainties, including an economic downturn or
slow economic growth, especially in Europe or North America; changes in currency
exchange rates and interest rates; introduction of competing products and
possible lack of acceptance of our products or services; competitive pressures
which may limit our ability to reduce sales incentives and raise prices; price
increases in fuel, raw materials, and precious metals; disruption of production
or delivery of new vehicles due to shortages of materials, labor strikes, or
supplier insolvencies; a decline in resale prices of used vehicles; our ability
to close the transaction with Cerberus Capital Management, L.P., regarding
Chrysler Group; the ability of the Chrysler Group to implement successfully its
Recovery and Transformation Plan; the business outlook for our Truck Group,
which may experience a significant decline in demand as a result of accelerated
purchases in 2006 made in advance of the effectiveness of new emission
regulations; effective implementation of cost reduction and efficiency
optimization programs, including our new management model; the business outlook
of our equity investee EADS, including the financial effects of delays in and
potentially lower volume of future aircraft deliveries; changes in laws,
regulations and government policies, particularly those relating to vehicle
emissions, fuel economy and safety, the resolution of pending governmental
investigations and the outcome of pending or threatened future legal
proceedings; and other risks and uncertainties, some of which we describe under
the heading "Risk Report" in DaimlerChrysler's most recent Annual Report and
under the headings "Risk Factors" and "Legal Proceedings" in DaimlerChrysler's
most recent Annual Report on Form 20-F filed with the Securities and Exchange
Commission. If any of these risks and uncertainties materialize, or if the
assumptions underlying any of our forward-looking statements prove incorrect,
then our actual results may be materially different from those we express or
imply by such statements. We do not intend or assume any obligation to update
these forward-looking statements. Any forward-looking statement speaks only as
of the date on which it is made.
Agriculture Department Warns Consumers of Tainted Raw Milk Sold by Berks County Dairy
-- Consumers who have purchased raw milk from Misty Meadow Farm in Bernville, Berks County, any time after April 16, 2007, should discard it immediately due to the risk of Listeria monocytogenes contamination, Agriculture Secretary Dennis Wolff said today.
"During routine inspection, a preliminary test showed the presence of Listeria bacteria in some of the raw milk samples taken from the Misty Mountain dairy," said Wolff. "If consumers have raw milk from this farm, they should discard it immediately."
There have been no illnesses reported because of the potential contamination, but if individuals who consumed the raw milk become ill, they are advised to consult their physician.
Raw milk is milk that has not been pasteurized or homogenized.
The Department of Agriculture has suspended sales of raw milk at the dairy and is ensuring that corrective action is taken. Samples were taken from the farm during routine testing on May 7, and tested positive for Listeria on May 10.
Multiple laboratory samples must come back negative before sales can resume.
Symptoms of Listeriosis are fever, muscle aches, and sometimes gastrointestinal symptoms such as nausea or diarrhea. If infection spreads to the nervous system, symptoms such as headache, stiff neck, confusion, loss of balance or convulsions can occur.
Infected pregnant women may experience only a mild, flu-like illness, but infections during pregnancy can lead to miscarriage or stillbirth.
Symptoms of Listeriosis can appear in four days to three weeks.
Interstate Brands Corporation Issues Recall of Mispackaged Hostess Mini Pound Cake Bearing Code Date MAY 28 53 122; Product May Contain Walnuts
FOR IMMEDIATE RELEASE -- Kansas City, MO -- May 10, 2007 -- Interstate Brands Corporation (IBC) is recalling the 3.25 oz. individual snack packages of Hostess® Mini Pound Cake with the code date of May 28 53 122, UPC #4500041159 due to a packaging error. It has been found that some Mini Pound Cake packages may in fact contain Hostess® Carrot Cake which is made with walnuts. People who have an allergy or severe sensitivity to walnuts run the risk of serious or life-threatening allergic reactions if they consume Hostess® Carrot Cake.
The recalled product has been distributed to retail stores throughout the states of Alabama, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Vermont, Virginia, District of Columbia, West Virginia, Wisconsin and portions of Missouri, Arkansas and Texas. The recall only covers Hostess® Mini Pound Cake with the code date of May 28 53 122.
The company learned of the error when a consumer in Michigan reported an allergic reaction to walnuts in the improperly packaged Hostess® Mini Pound Cake. One allergic reaction has been reported to date. No other Hostess® snack cake products are part of the recall, including Hostess® Carrot Cake 100 Calorie Packs, and there is no health risk for consumers who are not allergic to walnuts.
The code date of May 28 53 122 is printed on the center of the package just above the Hostess® Mini Pound Cake name and logo. Hostess® Carrot Cake can be identified through the clear film packaging by its white cream cheese icing. Hostess® Mini Pound Cake does not have icing.
Consumers that purchased the May 28 53 122 code dates of Hostess® Mini Pound Cake may return the product to the store where purchased for a full refund. Consumers with questions about the recall should call 1-800-483-7253.
FDA/USDA Joint News Release: Scientists Conclude Very Low Risk to Humans
from Food Containing Melamine
May 7, 2007
There is very low risk to human health from consuming meat from hogs and chickens known to have been fed animal feed supplemented with pet food scraps that contained melamine and melamine-related compounds, according to an assessment conducted by scientists from five federal agencies.
In the most extreme risk assessment scenario, when scientists assumed that all the solid food a person consumes in an entire day was contaminated with melamine at the levels observed in animals fed contaminated feed, the potential exposure was about 2,500 times lower than the dose considered safe. In other words, it was well below any level of public health concern.
The risk assessment is an important new science-based component of the continuing federal joint investigation into imported wheat gluten and rice protein concentrate from China that contained melamine and melamine-related compounds.
The risk assessment was conducted by scientists from the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) of the Department of Health and Human Services (HHS), the Environmental Protection Agency (EPA), U.S. Customs and Border Protection (CBP) of the Department of Homeland Security (DHS) and the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA). This team is now compiling a scientific assessment of the risk to animal health associated with ingestion of animal feed containing melamine and it