Information Center
Risk Management News: FDA Recalls
Food and Drug Administration--Recalls
Recall Information from FDA
Wegmans Food Markets, Inc. Issues Voluntary Recall on Wegmans Italian Classic...
Wegmans Food Markets, Inc. is initiating a voluntary recall of 24 oz. Wegmans Italian Classics Seasoned Tomato Sauce with a "use-by- date of 11/26/08", UPC 77890 79010.
Seattle's Favorite Gourmet Cookies and Dessert Co Issues Nationwide Allergy A...
Seattle's Favorite Gourmet Cookies and Dessert Co. is recalling Orange Cranberry and Banana Nut Muffin Tops because they contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life threatening allergic reaction if they consume these products.
CSI USA, Inc. Issues Voluntary National Recall of Topical Acne Cream (Novembe...
CSI, USA, Inc. issued a voluntary nationwide consumer product recall of all lots of 1 ounce (28 g) tubes of 10 Percent Benzoyl Peroxide Acne Cream with the following names: "DG Maximum Strength Acne Medicated Gel" (sold at Dollar General); "Kroger Acne Gel 10 Percent Benzoyl Peroxide Acne Medication" (sold at Kroger); and "Equate: Medicated Acne Gel" (sold at Wal-Mart).
Johnson and Johnson--Merck Consumer Pharmaceuticals Company Announces Urgent ...
Johnson and Johnson -- Merck Consumer Pharmaceuticals Company (JJMCP) is voluntarily recalling approximately 12,000 units of Infants' MYLICON GAS RELIEF DYE FREE drops (simethicone-antigas) non-staining sold in 1 oz. plastic bottles that were distributed after October 5, 2008 nationwide. The company is taking this action in consultation with the U.S. Food and Drug Administration (FDA). Although the potential for serious medical events is low, the company is implementing this recall to the consumer level as a precaution after determining that some bottles could include metal fragments that were generated during the manufacturing process. If any medical events were to occur, most are expected to be temporary and resolve without medical treatment. Parents who have given the product to their infant and are concerned should contact their health care provider immediately.
Nestle Withdraws Nestle Farinha Lactea Cereal in the United States (November 3)
Nestle is withdrawing Nestle Farinha Lactea cereal in the United States. Nestle is taking this action as we have learned that the product may contain residual traces of a pesticide not currently approved for use on wheat in the U.S. While the pesticide is approved for use in Brazil and the noted levels are well below Brazilian standards, it is not used on wheat products in the United States and therefore there is no set standard for its presence in cereal. The pesticide is permitted in the United States on grain crops other than wheat.
Amy's Kitchen Inc. Issues Allergy Alert and Voluntary National Recall due to ...
The products could cause an allergic reaction if consumed by any individuals allergic to milk. People who have an allergy or severe sensitivity to dairy products run the risk of serious or life-threatening allergic reaction if they consume the product. Consumers without milk allergies can safely consume the product.
ETHEX Corporation Initiated Nationwide Voluntary Recalls of Specific Lots of ...
ETHEX Corporation announced that it has voluntarily recalled to the consumer level specific lots of five generic/non-branded products that it markets. These lots have been recalled as a precaution, due to the possibility that they may contain oversized tablets. Oversized tablets may contain more than the intended levels of the active drug ingredient, which could result in patients receiving as much as about twice the expected dosage of these drugs.
Nestle USA Voluntarily Recalls Two Production Codes of Nestle Nesquik Strawbe...
The recall only includes two (2) production codes of 21.8-ounce containers of Nestle 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."
FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes (November 5)
The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death.
General Mills Issues Voluntary Class One Recall Involving One Day's Productio...
General Mills is voluntarily recalling a single day's production of Progresso Hearty Tomato soup because of a product labeling issue. Product produced on this date may have been mislabeled, and may contain allergens not listed on the ingredient label, specifically egg, milk, and soy.
Everlasting Distributors Inc. Issues a Nationwide Recall of Fresh and Crispy ...
Everlasting Distributors Inc., Bayonne NJ is initiating a nationwide recall of all their 3.88oz (110gm) packages of Fresh and Crispy Jacobina Biscuits because it may be contaminated with Melamine.
Mars Petcare US Issues Voluntary Recall of a Limited Number of Bags of SPECIA...
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.
Thoratec Corporation Issues Worldwide Medical Device Correction of HeartMate ...
Thoratec Corporation is initiating a worldwide medical device correction of all serial numbers of the HeartMate II Left Ventricular Assist Systems (HM II LVAS) having Catalogue No. 1355 or 102139, which have been distributed since the beginning of clinical studies in November 2003. Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump and potentially result in serious injury or death.
Nonna's Real Italiana Cuccine Issues an Allergy Alert on Undeclared Milk, Soy...
This product is distributed through retailers in the Greater New Orleans area including the Northshore from October 8, 2008 to October 17, 2008. The product is individually wrapped in clear plastic wrap bearing the label: "STUFFED ARTICHOKE, Net Wt. 15 oz., NONNA'S REAL ITALIANA CUCCINE".
Harry and David Issues Nationwide Allergy Alert on Undeclared Pecans in Harry...
Harry and David, of Medford, Oregon, is voluntarily recalling approximately 400 1 lb. 4 oz. boxes labeled Harry and 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.
Additional FDA news
FDA Orders Biomedical Tissue Services, Ltd., to Cease Manufacturing and to Retain Existing Inventories of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps)
Under its comprehensive framework for ensuring the safety of human tissue products, the U.S. Food and Drug Administration (FDA) today ordered Biomedical Tissue Services, Ltd. (BTS), of Fort Lee, NJ, a human tissue-recovery firm, and its CEO and Executive Director of Operations, Michael Mastromarino, D.D.S., to immediately cease all manufacturing operations. All tissue products initially recovered from human donors by BTS were recalled. FDA is carefully monitoring these recalls to account for all of the tissue distributed.
FDA Public Health Notification: Update of Information about BioMedical Tissue Services
FDA is issuing an update to its October 26, 2005, information paper on BioMedical Tissue Services (BTS) to strongly recommend that health care providers inform their patients who received tissue implants prepared from BTS donors that they may be at increased risk of communicable disease transmission and to offer them testing. As part of its ongoing investigation, FDA has become aware of additional information regarding the reliability of donor blood samples that is important for health care providers to consider