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Fineland Corp Issues Alert on Undeclared Sulfites in Ying Feng Foodstuffs Brand Pumpkin Seeds

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

FDA Updates Health Information Advisory on Melamine Contamination

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.

Ralston Foods Issues Allergy Alert For Undeclared Milk Ingredients In Western Family Variety Pack Instant Oatmeal

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.

Actavis Totowa Announces Voluntary Recall at the Retail Level of All Drug Products Manufactured at its Little Falls, New Jersey Facility

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
 

Answers to frequently asked questions regarding this market action can be found on www.actavis.us/RecallFAQ.

Manufacturer for Wegmans Brand Sorbet Issues an Allergen Alert for Undeclared Milk on a Limited Number of Wegmans Brand Sorbets

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:

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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Vita Food Products Issues Alert Regarding Vita Nova Salmon
Code Date of 11/16/08 198, Purchased on July 22 or After

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.

Federal Authorities Seize Xiadafil VIP Tablets After Company Refuses to Recall Product
Product contains undeclared ingredient that could harm consumers

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.

Agricola Zaragoza, Inc. Recalls Jalapeno Peppers Because of Possible Health Risk

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.

Agricola Zaragoza, Inc. Recalls Jalapeno Peppers Because of Possible Health Risk

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.

Domega International Co., Ltd. Issues an Alert on Undeclared Sulfites in Korica Brand Mut Gung Sweetened Ginger

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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Salmolux Inc. Recalls Wild Alaskan Smoked Salmon Nova Lox Lot # 01418 Because of Possible Health Risk

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.

Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of Select Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules, Products Marketed as Dietary Supplements, Containing an Undeclared Ingredient

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 -- 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.

FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes

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.

Orval Kent Foods Recalls Single Limited Production Run of Amish Macaroni Salad Sold Under the Orval Kent and Yoder’s Brand Names

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:

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.

International Pharmaceuticals, Ltd. Issues a Voluntary Recall of all Viril-Ity-Power (VIP) Tabs, a Product Marketed as a Dietary Supplement

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. 

FDA Shuts Down Seafood Processing Company, Requires Products Be Recalled
Failure to follow consent decree drives action

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.

Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalls all lots of Bertek and UDL Laboratories Digitek® (digoxin tablets, USP) as precaution

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.