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Risk Management News: FDA Recalls
Food and Drug Administration--Recalls
Recall information from FDA
Medtronic Initiates Voluntary Field Actions for Selected Heparin-Coated Produ...
Medtronic, Inc. announced that it is initiating a voluntary and precautionary recall of selected products featuring the Carmeda BioActive surface. The affected devices are disposable products used during cardiopulmonary bypass (CPB) for heart surgeries. Affected products include blood oxygenators, reservoirs, pumps, cannulae, and tubing packs.
Blount Fine Foods Issues Allergy Alert On Undeclared Shrimp in All Natural Ne...
Blount Fine Foods is recalling Blount All Natural New England Clam Chowder, Net Wt. 20 oz with Lot: 0424086D, Sell by date: 6/23/2008, because it may contain undeclared shrimp. People who have an allergy or severe sensitivity to shrimp run the risk of serious or life-threatening allergic reaction if they consume these products. The firm has recovered 1,400 of 1,416 units produced, 16 units are in distribution.
Updated Press Release: Lezza Blue Raspberry Italian Ice Recalled
The product is in round plastic pint containers with a lot code of 2116. Blue Raspberry is the flavor of the product. The product was distributed to retail outlets in Illinois, Wisconsin, Oklahoma, Texas, Michigan, Louisiana, Kansas, Indiana, Georgia, Florida, Ohio, Missouri, Kentucky, Nebraska, Pennsylvania, Arkansas, and Minnesota during 2006 and 2007.
Hydrox Labs Issued a Voluntary Recall of Alcohol-Free Mouthwash Nationwide Di...
Hydrox Labs has issued a voluntary recall of Cardinal Health labeled alcohol-free mouthwash. The mouthwash has been tested and been found positive for Burkholderia cepacia (B. cepacia). The CDC has confirmed hospital illnesses in one state associated with the use of the affected mouthwash.
Little Bay Baking Company Issues Nationwide Allergy Alert On Undeclared Soy I...
Little Bay Baking Company of Newmarket, New Hampshire is recalling all bags of CORN BREAD AND MUFFIN MIX sold before May 2, 2008 because it contains undeclared soy. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.
Lifetime Brands Voluntarily Recalls Certain Items Nationwide from its Pfaltzg...
Lifetime Brands, Inc., of Garden City, New York, today announced that, as a result of its internal compliance and independent product testing programs, it recently became aware that certain Pfaltzgraff Villa della Luna pattern and Nautica J Class pattern stoneware dinnerware products may exceed the Food and Drug Administration's guidance levels for lead and/or cadmium.
Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalls all lot...
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.
Allergy Alert on Undeclared Dairy in 11-Ounce Single Serve Silk Soymilk Choco...
WhiteWave Foods Company is voluntarily recalling 11-ounce plastic single serve bottles of Silk Soymilk Chocolate Flavor because it may contain undeclared milk protein.
DPH Issues Consumer Warning for Chang Farm Soy Sprouts Because of Bacteria Co...
The Department of Public Health (DPH) is issuing a warning to the public not to consume any soy sprouts produced from Chang Farms in Whatley, Massachusetts because of the presence of bacteria called Listeria monocytogenes (L. monocytogenes).
Fine Land Corp Issues Alert on Undeclared Sulfites in Ying Feng Foodstuffs Br...
Fine Land Corp, 239 Bay 20th Street Brooklyn NY 11214, is recalling its Ying Feng Foodstuffs brand Dried Bulbus Lily because it contains undeclared sulfites.
Fine Land Corp Issues Alert on Undeclared Sulfites in Golden Girl Brand "Mut ...
Fine Land Corp, 239 Bay 20th Street, Brooklyn, NY 11214 is recalling its Golden Girl brand "Mut Gung" sweetened ginger because it contains undeclared sulfites.
Fine Land Corp Issues Alert on Undeclared Sulfites in Ying Feng Foodstuffs Br...
Fine Land Corp, 239 Bay 20th Street Brooklyn NY 11214, is recalling its Ying Feng Foodstuffs brand dried snow fungus because it contains undeclared sulfites.
KFC Issues a Nationwide Allergy Alert, Recalls Unlabeled Double Chocolate Chi...
KFC Corporation is voluntarily recalling its Double Chocolate Chip Cakes because they contain eggs, milk, wheat, soy ingredients and possibly traces of tree nuts, and are not individually labeled with ingredient information.
Pulmuone Wildwood, Inc. Issues Allergy Alert on Undeclared Eggs in Leek and O...
Pulmuone Wildwood, Inc. is recalling 1,000 cases of Leek and Oriental Noodle Fried Dumplings, because they may contain undeclared eggs. The product affected is packaged in a white resealable 25.4 oz pouch with the UPC code 801114-306338 and the Code dates 2/2/2009, 2/9/2009 and 3/6/2009.
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