
Breaking News
Audience: Nephrology and hemodialysis healthcare professionals, hospital risk managers
[Posted 01/28/2010] FDA and Edwards Lifesciences notified healthcare professionals of a Class I recall of the Aquarius Hemodialysis System due to reports of clinically significant fluid imbalance and the potential for users to repeatedly override the fluid imbalance alarm. This could result in a decrease or increase in the volume of the circulating blood, which may result in serious injuries or death.
The recall includes model numbers: GEF08200, GEF09500, GEF09600, GEF09700, and GEF09800, using Software version 6.00.04. The product was distributed from July 12, 2007 through March 18, 2009. Baxter International, Inc. is the U.S. distributor of the Aquarius.
The company notified its customers of a planned software upgrade to prevent users from bypassing the fluid balance alarm more than five times in a 20-minute period.
[01/28/2010 - Recall Notice - FDA]
Rock Creek Nut Company Issues Allergy Alert on Undeclared Milk and Soy in "Quick Fix" Trail Mix
FOR IMMEDIATE RELEASE - December 7, 2009 - ROCK CREEK NUT COMPANY of Union, Oregon is recalling all "Quick Fix" trail mix, because it contains undeclared milk and soy in the carob chips. People who have an allergy or severe sensitivity to milk and/or soy run the risk of serious or life-threatening allergic reaction if they consume these products.
"Quick Fix" was distributed in Oregon and Washington at retail stores.
The product is packaged in clear plastic bags in ½ pound and 2 ounce sizes with a round blue and white label reading "Quick Fix", Rock Creek Nut Co. Union, Oregon 97885”. This product does not contain a lot code.
No illnesses have been associated with this product.
This recall is being conducted because it was discovered that "Quick Fix" product containing milk and soy was distributed in packaging that did not reveal the presence of milk and soy in the ingredient statement.
Customers who have purchased "Quick Fix" trail mix are requested to remove the product from distribution. Consumers with questions may contact the company at 1-541-562-5482 Monday through Friday between the hours of 9a.m. and 4p.m. Pacific time.
FOR IMMEDIATE RELEASE – November 12, 2009 – Westminster, CA – GMP Herbal Products, Inc. has been informed by the Food and Drug Administration (FDA) that Pai You Guo, a weight loss dietary supplement, sold and marketed by the firm contains undeclared drug ingredients. FDA lab analyses of dietary supplements distributed by the company were found to contain undeclared sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss; and phenolphthalein, a solution used in chemical experiments and a suspected cancer-causing agent that is not approved for marketing in the United States. The FDA has not approved the Pai You Guo products as drug; therefore the safety and effectiveness of this product is unknown. All lots of the following Pai You Guo product are being recalled. The product is sold either in a box of 30 capsules or a bag of 10 g powder.
The products listed above were sold and distributed nationwide via the internet.
FDA advises that these products pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
No illnesses or injuries have been reported to the company to date in connection with this product.
GMP Herbal Products, Inc. has taken this voluntary action because it is committed to providing accurate information about its products and because of the concern for the health and safety of consumers. GMP Herbal Products, Inc. is working with the FDA in the recall process. It sincerely regrets any inconvenience to customers.
Consumers are advised to destroy the above products or return them to the company’s address in Westminster, CA. Consumers with questions may contact GMP Herbal Products, Inc Tuesday through Saturday 11:00 am to 7:00 pm at 1-866-995-8585.
Any adverse reactions experienced with the use of this product 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 wwww.fda.gov/Safety/MedWatch/default.htm.
FOR IMMEDIATE RELEASE – August 12, 2009 – Peregrina Cheese Corporation of Brooklyn, New York, is recalling all products manufactured in its Brooklyn, NY plant from March 17, 2009 to the present 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.
This recall action is being conducted in accordance with the Consent Decree filed on July 20, 2009, which requires Peregrina Cheese Corporation to recall all products and codes produced in the Brooklyn plant from March 17, 2009 to the present.
The recall action involves the following products produced since March 17, 2009:
|
The products were distributed to retail stores in New York and Pennsylvania.
No illnesses have been reported to date.
This recall action is being conducted with the knowledge of the FDA.
Consumers who purchased the above listed products are urged not to consume them and to discard them immediately. Please direct questions regarding this recall action to Peregrina Cheese Corporation at 1-718-456-2391, Monday - Friday from 9 am - 4:30 pm EDT.
FOR IMMEDIATE RELEASE - July 28th, 2009 - Frontera Produce, of Edinburg, TX, is voluntarily recalling one lot of cilantro because it has the potential to be contaminated with salmonella. The company is working with the FDA to inform consumers of this recall, and no illnesses have been reported to date.
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.
The lot in question, 118122, was distributed to two retail store chains in Texas, Oklahoma, Colorado, Louisiana, and New Mexico. Both chains were provided with case tag identification and have been advised of the recall. Frontera Produce is issuing this voluntary recall as an additional measure to advise consumers to destroy the cilantro described above, purchased between July 20, 2009 and July 27, 2009. The cilantro bunches in question have a white twist tie with pink lettering spelling the word 'Cilantro' and the UPC number 033383801049.
The recall involves only one lot of cilantro and does not involve any other products.
This product originated in Mexico and was procured by Frontera Produce, who subsequently routinely tested for contaminants as part of their internal food safety program.
"Frontera Produce continues to stay committed to the highest levels of food safety, and strives to work within the industry to bring food safety to the forefront. We continually look for ways to enhance our protocol and stay committed to providing outstanding products to our consumers," said Will Steele, President and CEO.
Consumers with questions may contact Frontera Produce at 1(877)-381-5701, Monday-Friday, 9am-5pm central standard time, or email fpltd.mail@fronteraproduce.com.
Lewis Laboratories International, Ltd. Recalls Weigh Down Chocolate Flavor Nutrition Drink Mix Because of Possible Health Risk
FOR IMMEDIATE RELEASE -- July8, 2009 - Lewis Laboratories International, Ltd. is voluntarily recalling Weigh Down Chocolate Flavor Nutrition Drink Mix as a precautionary measure, Lot Numbers: 170C110 Best By Date 12/16/2011, 170C111 Best By Date 03/12/2012, 170C112 Best By Date 4/28/2012 and 170C113 Best By Date 6/5/2012 - Net Wt. 16 oz. (454 grams) >because it has 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 product was distributed to one distributor in NY and sold mail order through the Internet.
The product should not be used or consumed. Consumers who have any of the product are urged to destroy it. Lewis Laboratories has not received any notification of consumer illness associated with the consumption of its product.
The recall was initiated when Lewis Laboratories was notified by its supplier, that the product contained an ingredient supplied by Plainview Milk Products Cooperative, which has issued a voluntary recall on the non-fat dried milk and whey protein because of the potential to be contaminated with Salmonella.
Lewis Laboratories International, Ltd., says it expects to resume sales shortly.
Consumers with questions regarding the recall should contact Lewis Laboratories 1-800-243-6020 between 9:30 am and 5:00 pm EST .
Consumer contact:
David McLoughlin
866-803-2434
FOR IMMEDIATE RELEASE - Freeport, NY - July 28, 2009 - Nutracoastal Trading LLC announced today that it is conducting a voluntary nationwide recall of the company's dietary supplement product sold under the following name: STEAM.
The Company has been informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA for Lot 80214 found that the product contains sulfoaildenafil, an analog of sildenafil. Sildenafil is an active ingredient of an FDA-approved drug for erectile dysfunction (ED), making STEAM DIETARY SUPPLEMENT an unapproved drug. The active drug ingredient is not listed on the product label. The undeclared ingredient 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. Additionally, the product may cause side effects, such as headaches and flushing.
The recalled product listed below was distributed in white plastic bottles to retail stores nationwide.
|
Brand Name
|
Size
|
Lot
|
UPC
|
|---|---|---|---|
| STEAM | 1 Bottle - 5 Capsules | 80214 | 8 52263 30033 1 |
No illnesses have been reported to the company to date in connection with this 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.
Any adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program online [at www.fda.gov/MedWatch/report.htm], by phone [1-800-FDA-1088], or by returning the postage-paid FDA form 3500 [which may be downloaded from www.fda.gov/MedWatch/getforms.htm] by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178].
Nutracoastal Trading LLC, a Delaware Limited Liability Company, is committed to providing accurate information about its products because of concerns for the health and safety of consumers. Nutracoastal Trading LLC is working voluntarily with the FDA in the recall process. It sincerely regrets any inconvenience to customers.
Consumers should return any unused product to the retail location where they were purchased or contact Nutracoastal Trading LLC directly at 866-803-2434 Monday - Friday, 9 am to 5 pm EDT.
Max Muscle USA Conducts Voluntary Recall on Whey Protein Products Due to Possible Health Risks
FOR IMMEDIATE RELEASE – Anaheim, CA – July 3, 2009 – Max Muscle Sports Nutrition has issued a voluntary recall for Max Muscle products containing whey protein concentrate due to potential Salmonella contamination. This is an extension of the voluntary recall being conducted by one of the company’s suppliers, Plainview Milk Products Cooperative.
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. Max Muscle has not received any reports of illness related to the whey protein concentrate.
The products being recalled include 7 products and 101 lots. The products in question were manufactured in January and February of 2009, and distributed nationwide beginning in January of 2009. Only the products and lot numbers listed in the table below.
Max Muscle has provided information on the voluntary recall to its Chain of Franchises and retail customers nationwide who purchased the specific lots regarding this voluntary recall via fax, phone or mail. Max Muscle has notified the FDA of its actions and is fully cooperating with the Agency.
Customers are advised not to consume any of these products and should return them to the store where they were purchased for a full refund. Consumers with additional questions may call the Max Muscle Customer Service Department at 1-888-MAX-MUSCLE (1-888-629-6872), Extension 119, during normal business hours (Monday to Friday, 8:00 am to 5:00 pm, Pacific Standard Time).
| Max Gourmet | Lot # |
| Chocolate Banana Cream | 194644004-00909-1 |
| Chocolate Banana Cream | 194644004-01209-2 |
| Chocolate Banana Cream | 000194004-02809-1 |
| Chocolate Fudge Brownie | 194674002-01009-1 |
| Chocolate Fudge Brownie | 194674002-01009-2 |
| Chocolate Fudge Brownie | 194674002-01209-3 |
| Chocolate Fudge Brownie | 194674002-01209-4 |
| Chocolate Fudge Brownie | 194674002-01209-5 |
| Chocolate Fudge Brownie | 000224002-02809-1 |
| Peanut Butter | 194664006-00909-1 |
| Peanut Butter | 194664006-01209-1 |
| Peanut Butter | 000214006-02909-1 |
| Vanilla Caramel | 000204006-02809-1 |
| Strawberry | 000234001-02809-1 |
| Max Gourmet Gainer |
|
| Chocolate | 00001402-02909-1 |
| Chocolate | 00001402-02909-2 |
| Chocolate | 00001402-03609-1 |
| Chocolate | 00001402-03609-2 |
| Vanilla | 000024000-03609-1 |
| Vanilla | 000024000-03509-1 |
| Strawberry | 000034001-02909-1 |
| Strawberry | 000034001-03609-1 |
| Max Lean |
|
| Chocolate | 194703002-01409-1 |
| Chocolate | 194703002-01409-2 |
| Vanilla | 194713000-01309-1 |
| Strawberry | 194723001-01309-1 |
| High Five |
|
| Pineapple Banana | 19461502-01409-1 |
| Pineapple Banana | 19461502-01409-2 |
| Pineapple Banana | 19461502-01409-3 |
| Pineapple Banana | 19461502-05409-1 |
| Pineapple Banana | 19461502-05409-2 |
| Banana | 19652501-05509-1 |
| Chocolate | 19459506-01509-1 |
| Chocolate | 19459506-01509-2 |
| Chocolate | 19459506-01509-3 |
| Chocolate | 19459506-01509-4 |
| Chocolate | 19459506-01609-5 |
| Chocolate | 19459506-01609-6 |
| Chocolate | 00015506-03309-1 |
| Chocolate | 00015506-03309-2 |
| Chocolate | 00015506-03309-3 |
| Chocolate | 00015506-03309-4 |
| Cappuccino | 19458505-01609-1 |
| Orange | 19358504-01409-1 |
| Orange | 19358504-01409-2 |
| Strawberry | 19456203-01509-1 |
| Strawberry | 19456203-01509-2 |
| Strawberry | 19456203-01509-3 |
| Strawberry | 19456203-01509-4 |
| Strawberry | 1965750305509-1 |
| Strawberry | 1965750305609-2 |
| Strawberry | 1965750305609-3 |
| Vanilla | 19658500-05409-1 |
| Vanilla | 19463500-01209-2 |
| Vanilla | 19463500-01309-3 |
| Vanilla | 19463500-01309-4 |
| Vanilla | 19463500-01309-5 |
| Vanilla | 19658500-05409-2 |
| Vanilla | 19658500-05509-3 |
| Vanilla | 19658500-05509-4 |
| Vanilla | 19658500-05509-5 |
| Vanilla | 19658500-05409-1 |
| Big Max 50 |
|
| Chocolate | 19444009-01609-1 |
| Chocolate | 19444009-01609-2 |
| Chocolate | 19444009-01609-3 |
| Chocolate | 19444009-01609-4 |
| Chocolate | 19444009-01609-5 |
| Chocolate | 19444009-01609-6 |
| Chocolate | 19444009-01609-7 |
| Chocolate | 19444009-01609-1 |
| Chocolate | 19444009-01609-2 |
| Chocolate | 19444009-01609-3 |
| Vanilla | 19446008-01309-1 |
| Vanilla | 19446008-01309-2 |
| Vanilla | 19446008-01309-3 |
| Vanilla | 19446008-01309-4 |
| Vanilla | 19446008-01309-5 |
| Strawberry | 19449010-01509-1 |
| Strawberry | 19449010-01509-2 |
| Strawberry | 19449010-01509-3 |
| Strawberry | 19449010-01509-4 |
| Triple Whey |
|
| Chocolate | 194875001-02009-1 |
| Chocolate | 194875001-02009-1 |
| Chocolate Cream | 000335001-03009-1 |
| Chocolate Cream | 194875001-02109-3 |
| Chocolate Cream | 194875001-02109-4 |
| Chocolate Cream | 194875001-02109-4 |
| Strawberry Cream | 000345000-03009-1 |
| Vanilla Cream | 000335002-03009-1 |
| Max Pro |
|
| Natural Vanilla | 00028611-03509-1 |
| Natural Vanilla | 00028611-03509-2 |
| Vanilla, | 00027606-03509-1 |
| Vanilla | 00027606-03509-2 |
| Vanilla | 00027606-03509-3 |
| Vanilla | 00027606-03509-4 |
| Vanilla | 00027606-03509-5 |
| Vanilla | 00027606-03509-6 |
| Banana | 00024609-03509-1 |
| Banana | 00024609-03509-2 |
| Strawberry | 0002603-04109-1 |
| Orange Blast | 00029608-03509-1 |
McClancy Seasoning Co. Voluntarily Recalls Alba Instant Non-Fat Dry Milk Products and Various Alba Snack Shake Mixes Because of the Possible Presence of Salmonella
)
FOR IMMEDIATE RELEASE -- Fort Mill, SC - July 2, 2009 - McClancy Seasoning Co. announced that it is recalling Alba Instant Non-Fat Dry Milk (25.6 oz), Alba Instant Non-Fat Dry Milk (9.6 oz), Alba Creamy Milk Chocolate Snack Shake Mix (6 oz), Alba Double Fudge Royale Snack Shake Mix (6 oz), Alba Smooth Vanilla Bean Snack Shake Mix (6 oz) and Alba Strawberry Banana Snack Shake Mix (6 oz). These products contain instant non-fat dry milk supplied by Plainview Milk Products Cooperative, which is voluntarily recalling this ingredient because it has the potential to be contaminated with Salmonella. No illnesses have been reported in connection with the products listed above.
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. For more information on Salmonella, please visit the Centers for Disease Control and Prevention’s website at http://www.cdc.gov.
The recalled products are distributed nationwide by the Alba Company to distributors and retailers. The affected products and lots are as follows:
| Alba Instant Non-Fat Dry Milk (25.6 oz) | UPC# 13000-02801 |
Lots 21MAR09 thru 21NOV10 |
|
| Alba Instant Non-Fat Dry Milk (9.6 oz) | UPC# 13000-02831 |
Lots 03APR09 thru 04DEC10 |
|
| Alba Creamy Milk Chocolate Snack Shake Mix UPC# 13000-02837 | Lots 19APR09 thru 24OCT10 | ||
| Alba Double Fudge Royale Snack Shake Mix | UPC# 13000-02839 |
Lots 14MAR09 thru 23OCT10 |
|
| Alba Smooth Vanilla Bean Snack Shake Mix | UPC# 13000-02841 |
Lots 06MAR09 thru 22OCT10 |
|
| Alba Strawberry Banana Snack Shake Mix | UPC# 13000-02843 |
Lots 11MAR09 thru 06APR10 |
Consumers who have purchased any products covered by this recall are urged to return them to the store of purchase for a full refund. Consumers with questions or concerns about the recall may call the consumer hotline at 1-800-434-4246, Monday-Friday, 9am-7pm Eastern Time. Consumers with questions or concerns about their health should contact their doctor.
FOR IMMEDIATE RELEASE -- July 2, 2009 - Precision Foods Inc., of St. Louis, Missouri, is recalling certain Madagascar Vanilla cocoa as a precaution given that the potential exists that the product may be contaminated with Salmonella. The company is conducting this voluntary recall because of a notification Precision Foods received from two of its suppliers, AMFOTEK and Plainview Milk Products Co-op, regarding Plainview’s Instant Non-Fat Dry Milk recall. Although the product has not been found to contain Salmonella and no illnesses have been reported to date, as a precaution, production and distribution of the product has been suspended while the FDA and the company continue their investigations into the suppliers’ issues.
The cocoa product that is the subject of this voluntary recall is labeled as Land O Lakes International Drinking Cocoa “Madagascar Vanilla”. The product is packed in 12.5 ounce foil bags marked with “Best By 09/04/10” or “Best By 11/05/10” in the lower right hand corner of the rear panel of the package. The UPC is 8 78326 00071 0. This is the only product involved in this recall.
The product was distributed nationally in retail stores and through mail orders.
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.
Consumers who have purchased the Madagascar Vanilla cocoa are urged to return them to the place of purchase for a full refund. Consumers who want additional information may call 1-877-585-2365.
FOR IMMEDIATE RELEASE -- July 2, 2009 - Meijer has initiated a voluntary recall of one type of its Meijer Brand Instant Non-fat Dry Milk because it has 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.
Meijer Brand Instant Non-fat Dry Milk was sold in Meijer stores in Michigan, Ohio, Indiana, Illinois and Kentucky. Meijer has removed all identified products from its stores.
The product under recall is
Meijer Instant Non-fat Dry Milk, 10 QT Packets, UPC # 00000000-41250-96746-0,
with the following two sell-by dates: FEB0911S and FEB1011S. The sell-by date is
printed on the top of the box by the opening.
While this Meijer brand product has not been identified as contaminated or
linked to any illness, Meijer has received these products from Plainview Milk
Products Cooperative in Plainview, Minnesota, which has been verified as a
potential source of Salmonella - contaminated products.
Meijer requests that customers who have purchased these products destroy the product or return them to any Meijer location for a full refund. If Meijer customers are unsure if they have the recalled product, they are requested to bring in the product for determination or contact the Meijer customer contact center at 800-543-3704 (available 24/7). Consumers with questions or concerns about their health should contact their health care provider. If symptoms are present, please visit a health care provider or go to a hospital emergency room.
"The safety of our customers is always our number one priority," said Frank J. Guglielmi, director of public relations for Meijer. "Meijer has taken these precautionary steps to help protect our customers and will return this product to our stores only once it is safe for our shoppers."
For more information on Salmonella, please visit the Centers for Disease Control and Prevention’s Website at http://http://www.cdc.gov.
FOR IMMEDIATE RELEASE -- May 28, 2009 -- Chang Farm, River Road, Whatley, MA is issuing a voluntary recall of Bean and Soy sprouts produced from Chang Farms, with specific expired date codes because of the possible presence of Listeria monocytogenes (L. Monocytogenes) contamination. 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 affected product is packaged in 10 lb bags (bulk) and 12 oz plastic bags (retail), labeled under the Chang Farm Brand as Soy Sprouts and have a “Sell By” date of May 23, 2009 or May 24, 2009 and Bean Sprouts with “Use By” date of May 23, 2009 or May 24, 2009.
The product has been distributed to retail stores and restaurants throughout MA, CT, NY and NJ.
No illnesses have been reported to date.
The contamination was discovered after a sample was secured at a retail store in New York which tested positive for L. monocytogenes
All grocery stores, food services, and other retailers who have this lot in MA, CT, NY and NJ should remove this product from their shelves. Consumers should discard this product or return them to the place of purchase for a full refund.
Consumers should contact their healthcare provider with any illness concerns. Consumers with questions about the warning may contact Chang Farm at 413-665-3341.
FOR IMMEDIATE RELEASE -- Libertyville, IL, May 11, 2009 – A S Medication Solutions, LLC, a drug repackage company, announced today that all tablets of Caraco brand Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of August, 2011, are being voluntarily recalled to the consumer level. The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin. Caraco Pharmaceutical Laboratories, Ltd manufactured the recalled tablets. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Digoxin is a drug product used to treat heart failure and abnormal heart rhythms. It has a narrow therapeutic index and the existence of higher than labeled dose may pose a risk of digoxin toxicity in patients with renal failure. Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and slow heart rate. Death can also result from excessive digoxin intake. A lower than labeled dose may pose a risk of heart failure and abnormal heart rhythms.. Consequently, as a precautionary measure, A S Medication Solutions, LLC is recalling these tablets to the consumer level to minimize any potential risk to patients.
Consumers with the products with the following NDC codes that are within expiration should return these products to the place of purchase.
Product Identification
Caraco Digoxin
A-S Medication Solutions, Digoxin 0.25 mg is a scored round biconvex white
tablet imprinted with “441”
NDC Numbers:
Digoxin Tablets, USP, 0.25 mg
54569-5758-0 (30-count)
Patients using A-S Medication Solutions, Digoxin tablets, USP, 0.25 mg, who have medical questions should contact their healthcare provider for additional instructions or guidance.
Healthcare providers who have this product should return the product to their place of purchase. Healthcare providers can call A-S Medication Solutions Recall Coordinator at (847) 680-3515, Monday through Friday, 8:00 a.m. – 4:00 p.m. CST, for instructions on how to return the affected product or for any other inquiries related to this action.
Any adverse reactions experienced with the use of all affected 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 Med Watch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
FOR IMMEDIATE RELEASE -- HEREFORD, TX -- February 20, 2009 --- Arrowhead Mills, Inc. announced that it is taking the precautionary measure of recalling Arrowhead Mills® Organic Stone Ground Whole Wheat Flour (2 lbs.) with a lot code of 06OCT09 because of the possibility of the presence of an undeclared dairy allergen in a limited number of bags within this lot. The lot code is located on the right side of the upper front panel of the individual bag of flour. No other lot codes of this product or any other Arrowhead Mills products are affected in any way and there have been no reported illnesses.
Consumers who have an allergy or severe sensitivity to milk protein run the potential risk of a health problem or illness if they consume this product.
The recalled product was distributed to natural food stores nationwide. Arrowhead Mills is working with distributors to actively recover any affected product remaining on store shelves.
Arrowhead Mills® Organic
Stone Ground Whole Wheat Flour (2 lbs.)
Unit UPC code # 74333-47242
Lot code: 06OCT09
Consumers who have purchased any products covered by this recall are urged to return them to the store of purchase for a full refund. Consumers with questions or concerns about the recall may call the company at 1-800-749-0730, Monday-Friday, 7am-5pm Mountain Time.
The historic inauguration of Barack Obama as the 44th President of the United States is now fast upon us. Even if you aren’t making the trip to the capital, there are many ways to participate and follow the festivities from afar. Yahoo! News and the Yahoo! media network will be bringing you loads of stories, photos, live video and commentary.
Here's a brief look at the four-day schedule and some ways to participate (A full schedule can be found at the website for the Presidential Inaugural Committee):
Saturday,
Barack Obama and Joe Biden
went on a
whistle-stop train tour
starting in Philadelphia,
the birthplace of our democracy.
Sunday, Obama helped to kick off the inaugural celebration with
an open event at the Lincoln Memorial,
featuring an all-star line-up of music artists, including
U2,
Bruce Springsteen and
Usher. The Rt. Reverend V.
Gene Robinson gave the invocation.
Monday is
Martin Luther King Day.
Gen. Colin Powell is leading an effort to promote
community involvement and volunteer service with the
Renew
America Together initiative. Information on
activities near you can be found at
USAservice.org.
The Obama and Biden families will be participating in D.C. service events in
honor of
Dr. Martin Luther King. A ‘Kids Inaugural’ concert will be held later
that evening in honor of military families. Private dinners honoring Gen.
Powell, Sen. John McCain
and Joe Biden will also be held.
Tuesday, Jan.20, 2009 is
Inauguration Day, including the swearing-in ceremony, a parade
and countless inaugural balls.
Swearing-in ceremony festivities commence at 10:00 a.m. EST, 7:00 a.m. PST.
Highlights include:
• Invocation: Dr. Rick Warren
• Musical Selection: Aretha
Franklin
• Vice President-elect
Joseph R. Biden will be sworn into office
• Musical Selection: John Williams with Itzhak Perlman, Yo-Yo Ma , Gabriela
Montero and Anthony McGill
• President-elect Barack
H. Obama will take the Oath of
Office, using President Lincoln’s Inaugural Bible
•
Inaugural Address
• President Obama escorts
outgoing President George W. Bush to a departure ceremony
• Poem: Elizabeth Alexander
• Benediction: The Reverend Dr. Joseph E. Lowery
• The National Anthem: The United
States Navy Band “Sea Chanters"
The 56th Inaugural Parade begins around 2:30 p.m. EST, making its way from the
Capitol to the White House.
The ‘Neighborhood Inaugural Ball,’ hosted by President Obama begins at 7:00 p.m. EST and will be broadcast on ABC. The Presidential Inaugural Committee site casts it as “the premier event of the night” with performances by Stevie Wonder, Beyonce and others. Other ‘neighborhood’ parties across the country will also be webcast and linked to.
FOR IMMEDIATE RELEASE -- January 10, 2009—Café Favorites has initiated a recall of their Whole Grain 5" Super Sub with daycode starting with 08343XXX because it may 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 still births among pregnant women.
The product was sold to distributors in Maryland, Florida, Massachusetts, and Pennsylvania. The distributors in Florida, Massachusetts, and Pennsylvania did not further distribute the product. The distributor in Maryland sold product to one school in the Washington DC area, where it was served. Students and staff should dispose of these sandwiches if they took them home. Anyone experiencing symptoms should consult their doctor.
The product description of product that has been recalled:
Product Name: Whole Grain 5"
Super Sub
Product Code: 02384
Day Code: 08343
Packaged: 5.4 oz portion, 84/case
No illnesses associated with this product have been reported to date. The recall was voluntarily initiated by Café Favorites after a routine FDA inspection.
Consumers with question may contact the company at 218-685-6500 during 8:00am-5:00pm central time.
FOR IMMEDIATE RELEASE --Ann Arbor, Mich. -- December 1, 2008 --- Terumo Cardiovascular Systems (Terumo CVS) is issuing an urgent, nationwide/worldwide recall of its Tenderflow™ Pediatric Arterial Cannulae involving 21 lot codes (see information below). Terumo received five reports of difficulty retracting the introducer from the cannula. When the introducer cannot be retracted from the cannula, the cannula must be removed and replaced, a process that may lead to aortic damage, blood loss and/or death.
There have been no reports of patient injury or death associated with the product.
| Tenderflow™ Pediatric Arterial Cannula Catalog and Lot Numbers Affected | |
| Catalog Number | Lot Number |
| 813568 | 0501639, 0512002 |
| 813567 | 0501557, 0512008 |
| 813570 | 0502200, 0513069 |
| 813569 | 0502199, 0513068, 0517852 |
| 813572 | 0507121, 0512918 |
| 813571 | 0507120, 0512919, 0518680 |
| 813574 | 0509240 |
| 813573 | 0509238, 0517874 |
| 813576 | 0509241 |
| 813575 | 0500759, 0513331 |
| 813578 | 0500760 |
| 813577 | 0502878 |
An arterial cannula is a disposable tube inserted in the aorta during many cardiac bypass surgery procedures and is used to perfuse the ascending aorta. The cannula is inserted using an introducer, which stabilizes the cannula during insertion and is then removed.
Terumo CVS distributed this product directly to 68 U.S. hospitals, and has notified all of the hospitals of the voluntary recall in a letter dated Oct. 16, 2008. The product was also distributed from distribution centers in Australia, Canada and Europe. The notification letter recommended that customers not use the product unless medically necessary. In those cases, the cannula should be used without the introducer. Clinicians with questions may contact the company at 800-521-2818, or if calling from outside the U.S., 734-663-4145. Contact can be made Monday-Friday from 8:00 a.m. to 5:00 p.m. EST.
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.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 |
Terumo informed the U.S. Food and Drug Administration of this recall. Terumo Cardiovascular Systems Corporation is a global manufacturer and marketer of medical devices for cardiac and vascular surgery. The company is headquartered in Ann Arbor, Michigan with manufacturing operations in Ann Arbor; Elkton, Maryland; Ashland, Massachusetts; and Tustin, California. For more information, visit www.terumo-cvs.com.
FOR IMMEDIATE RELEASE -- November 24, 2008--- Balanced Health Products, Inc. is voluntarily recalling STARCAPS DIET SYSTEM DIETARY SUPPLEMENT, Lot 12/2011 – 84810, sold in 30 capsule plastic bottles.
The recall is effective immediately and is being undertaken because this lot of STARCAPS contains 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.
To date, this recall only applies to Lot 12/2011 – 84810. The company is in the process of testing other lots and will notify the FDA of its results, as well as, if additional lots are to be recalled.
The recalled lot totaling 1,974 consumer-size bottles were distributed nationwide from August 2008 to October 30, 2008 through retail outlets and online sales.
Consumers who purchased STARCAPS Lot 12/2011 – 84810 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.
Any adverse reactions experienced with the use of this product 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, HF-410, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at wwww.fda.gov/medwatch.
FOR IMMEDIATE RELEASE -- FRANKLIN, Tenn. – October 27, 2008 – Mars Petcare US today announced a voluntary recall of a limited number of bags of SPECIAL KITTY® Gourmet Blend dry cat food sold at Wal-Mart locations in Connecticut, Delaware, Massachusetts, Maryland, Maine, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Virginia, Vermont, and West Virginia. The pet food is being voluntarily recalled following a positive test result indicating a potential contamination with Salmonella.
This product should not be sold or fed to pets. Pet owners should dispose of product in a safe manner (example, a securely covered trash receptacle) and return the empty bag to the store where purchased for a full refund.
Salmonella can cause serious infections in dogs and cats, and, if there is cross contamination caused by handling of the pet food, in people as well, especially children, the aged, and people with compromised immune systems. Healthy people potentially infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. On rare occasions, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.
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. Animals can be carriers with no visible symptoms and potentially infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.
There have been no complaints or reports of illness resulting from consumption or handling of the recalled product.
Pet owners who have questions about the recall should call 1-877-568-4463 or visit www.petcare.mars.com.
Recalled Pet Food
Product: SPECIAL KITTY® Gourmet Blend Dry Cat Food
Best If Used By Date: AUG 11 09
Best If Used By Date Location: Back of bag
Production Lot Code: 50 XXXX X (Found on back of bag just
after "Best If Used By" date. Consumers should look for "50" as the first two
digits of the second line.)
UPC Code: UPC code numbers can be found directly underneath the
bar code on the package. Please find recalled pet food UPC information below.
| 3.5 lb. | SPECIAL KITTY® Gourmet Blend | 81131 17546 |
| 7 lb. | SPECIAL KITTY® Gourmet Blend | 81131 17547 |
| 18 lb. | SPECIAL KITTY® Gourmet Blend | 81131 17548 |
Affected Stores: Wal-Mart locations in Connecticut, Delaware, Massachusetts, Maryland, Maine, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Virginia, Vermont, and West Virginia.
In an effort to prevent the transmission of Salmonella from pets to family members and care givers, the FDA recommends that everyone follow appropriate pet food handling guidelines when feeding their pets. A list of safe pet food handling tips can be found at: www.fda.gov/consumer/updates/petfoodtips080307.html
Pet owners who have questions about the recall should call 1-877-568-4463 or visit www.petcare.mars.com.
FOR IMMEDIATE RELEASE -- Sparks, MD -- September 30, 2008 – McCormick & Company, Incorporated has announced a voluntary recall of McCormick Enchilada Sauce Mix with UPC Code 52100091600 sold under the McCormick brand. The McCormick Enchilada Sauce Mix contains undeclared milk ingredients. People who have allergies to milk run the risk of serious or life threatening allergic reactions if they consume this product.
The McCormick Enchilada Sauce Mix was distributed to grocery stores nationally beginning on September 17, 2008. The product comes in 1.5 oz. pouches with an expiration date of "best by" AUG2910CH. The date is found printed in black on the back, bottom left of the pouch.
The recall was initiated after it was discovered that product containing the milk ingredient was distributed in packaging that did not reveal the presence of milk as an ingredient.
No illnesses or allergic reactions have been reported to date. No other McCormick products are involved in this recall.
All grocery outlets that sell McCormick Enchilada Sauce Mix (UPC Code 52100091600 with expiration date "best by" AUG2910CH) have been notified to remove the product from their shelves immediately, and consumers who have purchased this product should return it to the place of purchase for a full refund. Consumers with questions may contact McCormick at 1-800-632-5847.
This recall is being made with the knowledge of the Food and Drug Administration.
(C) MBN 2008