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FDA Announcements
National Brands Inc. Issues a Nationwide Recall of Topaz brand Wafer Rolls Because of Possible Health Risks (December 19)
01/05/09
National Brands Inc., Spring Valley NY is initiating a nationwide recall of all their 4.76oz (135gm) cans and 12.3oz (350gm) cans of Topaz brand Wafer Rolls because it may be contaminated with Melamine.
FDA Announces Class I Recall of Ophthalmic Surgical Device
01/02/09
The U.S. Food and Drug Administration announced a Class I recall of lot no. UD30654 of Healon D, an ophthalmic viscosurgical device (OVD) manufactured by Advanced Medical Optics Inc. (AMO) of Santa Ana, Calif.
Stryker Craniomaxillofacial Issues Nationwide Recall of its Custom Cranial Implant Kits; Catalogue Numbers 54-00101, 54-00102, 54-00103 and 54-00104, all lots shipped sterile (December 23)
12/31/08
Stryker's Craniomaxillofacial (CMF) business unit announced today that the U.S. Food and Drug Administration (FDA) concluded on Dec. 18, 2008 that its recall of the following Stryker CMF's Custom Cranial Implant Kits is a Class I recall, which means...
KRC Food Trading Inc. Recall of Fish Cake Sushi (December 23)
KRC Food Trading Inc is recalling its Fish Cake sushi with production date of December 19 and December 22 due to the label not declaring eggs. People who have an allergy or severe sensitivity to eggs run the risk of serious or...
KV Pharmaceutical Voluntarily Suspends All Shipments of its Approved Tablet-form Drugs (December 23)
12/23/08
KV Pharmaceutical has advised the U.S. Food and Drug Administration (FDA) that, effective midnight Dec. 19, 2008, the company voluntarily suspended all shipments of all FDA approved drug products in tablet form. KV Pharmaceutical is also recalling a...
ETHEX Corporation Initiated Nationwide Voluntary Recall of a Single Lot of Hydromorphone HCl 2 mg Tablets Due to Potential for Oversized Tablet (December 23)
12/23/08
ETHEX Corporation announced today that it has voluntarily recalled to the consumer level, a single production lot of Hydromorphone HCl 2 mg tablets (Lot #90219, Exp: 03/2010; NDC #58177-0620-04), as a precaution, due to the possibility it may...
FDA Warns Consumers About Tainted Weight Loss Pills (December 22)
12/22/08
The U.S. Food and Drug Administration is alerting consumers nationwide not to purchase or consume more than 25 different products marketed for weight loss because they contain undeclared, active pharmaceutical ingredients that may put consumers'...
Dorsey Marketing Inc. Voluntarily Recalls Three G and J Gourmet Market Cocoa Products: 120126, 120129, 120144 (December 19)
12/20/08
Dorsey Marketing Inc. (DMI) of Ville St. Laurent, Quebec, Canada, is voluntarily recalling the following three G and J Gourmet Market cocoa products because these products may contain melamine.
Interfood Shareholding Company Issues a Nationwide recall of Wonderfarm Brand Biscuits Because of Possible Health Risk (December 9)
12/18/08
Interfood Shareholding Company is recalling all lot codes of multiple varieties of the Wonderfarm brand of biscuits because they may be contaminated with Melamine.
FDA Announces Class I Recalls of Two Unapproved Devices (December 15)
12/15/08
The U.S. Food and Drug Administration (FDA) announced a Class 1 recall today for two unapproved and uncleared devices whose manufacturers claimed could treat various medical conditions. A Class 1 recall means that there is a reasonable probability...
Kashi Company Issues Allergy Alert on Undeclared Milk in Kashi GOLEAN Powder Chocolate Energy Shake Mix (December 13)
12/15/08
The product is packaged in a 14.8 oz canister with a bar code of 18627 71000. Canisters with a Better if Used by Date stamped on the bottom of the canister between the dates of JAN 17 2009 and NOV 15 2009 are included in this alert.
Cambrooke Foods Voluntarily Recalls All Low Protein Imitation Cream Cheese Products Because of Possible Health Risk (December 12)
12/14/08
Cambrooke Foods, LLC, of Framingham, MA, is announcing a voluntary recall of all batches of its Low Protein Imitation Cream Cheese ("Cheddar Wizard," "Herb and Garlic," and "Plain" flavors).
FDA Warns Consumers and Retailers of Botulism Risk from Ungutted, Salt-Cured Alewives (Gaspereaux) Fish (December 12)
12/12/08
The U.S. Food and Drug Administration is warning retailers and food service operators not to offer for sale ungutted, salt-cured alewives (also called gaspereaux fish) from Michel and Charles LeBlanc Fisheries Ltd., CAP-PELE, New Brunswick, Canada,...
Hospira Issues Voluntary Recall of One Lot of 20meq Potassium Chloride in 5 Percent Dextrose and 0.45 Percent Sodium Chloride Injection, USP Due to Incorrect Bar Code Label (December 8)
12/09/08
The incorrect bar code could lead to a medication error resulting in the wrong drug being delivered to a patient if a bar code system is used to confirm the medication. Potential adverse events related to an error of this type include electrolyte...
Balanced Health Products, Inc. Expands Voluntary Urgent Nationwide Recall of Starcaps Dietary Supplement Capsules Found to Contain an Undeclared Drug Ingredient (December 8)
12/08/08
Balanced Health Products, Inc. has expanded its voluntarily recall of STARCAPS DIET SYSTEM DIETARY SUPPLEMENT to include additional Lot Numbers 12/2009 - 82866 and 12/2010 - 83801, sold in 30 capsule plastic bottles.
Terumo Cardiovascular Systems Issues Urgent, Nationwide/Worldwide Recall of Pediatric Arterial Cannulae (December 1)
12/08/08
Terumo Cardiovascular Systems (Terumo CVS) is issuing an urgent, nationwide/worldwide recall of its Tenderflow Pediatric Arterial Cannulae involving 21 lot codes.
Louisiana Fish Fry Products Issues Nationwide Allergy Alert on Undeclared Buttermilk in Chicken and Fish Bake Seasoned Coating Mix (December 5)
12/06/08
The recalled Chicken and Fish Bake was distributed nationwide in retail stores and through mail orders. The product comes in a 6 ounce bag marked with a "Best By" date from Jan 1, 2008 thru Sept. 25, 2011.
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