FDA Recalls
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 life-threateningallergic reaction if they consume these products. The Fish cake Sushi was distributed in California in coffee shops, bakeries, and Korean markets in Los Angeles, CA including two retail stores owned by the firm.…
Celeste Industries Corporation Recalls All Lots of simplySmart Remove Make Up Remover (January 5)
Celeste Industries Corporation has voluntarily recalled all lots of simplySmart Remove Make Up Remover in the US and Canada This product is packaged as a single towelette with hiexpress.com shown on the packet. This recall was a result of certain limited lots testing positive for Pseudomonas aeruginosa bacteria.…
National Brands Inc. Issues a Nationwide Recall of Topaz brand Wafer Rolls Because of Possible Health Risks (December 19)
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
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)
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 the product could pose an imminent hazard to health: Catalogue Numbers 54-00101, 54-00102, 54-00103 and 54-00104, all lots shipped sterile. The notification relates to a nationwide voluntary recall initiated by Stryker CMF on Oct. 24, 2008 of 322 Custom Cranial Implant Kits after determining that the sterilization validation of the product was not performed according to appropriate standards.…
KV Pharmaceutical Voluntarily Suspends All Shipments of its Approved Tablet-form Drugs (December 23)
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 single production lot of Hydromorphone HCl 2 mg tablets (Lot 90219, Exp: 3/2010; NDC 58177-0620-04), a pain management drug, following the report of an oversized tablet.…
ETHEX Corporation Initiated Nationwide Voluntary Recall of a Single Lot of Hydromorphone HCl 2 mg Tablets Due to Potential for Oversized Tablet (December 23)
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 contain oversized tablets. Hydromorphone is a drug used for pain management and is packaged under the ETHEX label in 100-count bottles.…
FDA Warns Consumers About Tainted Weight Loss Pills (December 22)
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' health at risk.…
Dorsey Marketing Inc. Voluntarily Recalls Three G and J Gourmet Market Cocoa Products: 120126, 120129, 120144 (December 19)
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)
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)
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 that the use of a device will cause adverse health consequences or death.…
Kashi Company Issues Allergy Alert on Undeclared Milk in Kashi GOLEAN Powder Chocolate Energy Shake Mix (December 13)
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)
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)
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, because the fish may contain the Clostridium botulinum (C. botulinum) toxin. Consumers should not consume the product.…
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)
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 imbalance, cardiac dysfunction, gastrointestinal disturbances, paresthesia and mental confusion.…
Balanced Health Products, Inc. Expands Voluntary Urgent Nationwide Recall of Starcaps Dietary Supplement Capsules Found to Contain an Undeclared Drug Ingredient (December 8)
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)
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)
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.…
Walgreens Recalls 173 Teddy Bears With Chocolate Bars Sold Since Late September 2008 (December 5)
Walgreens already has instructed stores to stop selling the product, which is specifically described as an approximately 9-inch high Dressy Teddy Bear with 4-oz. Chocolate Bar. The product's UPC number is 047475864485, and the product tag also includes the item number 291332. Walgreens has not received any reports of illness or injury related to this product.…
Mom's Food Products, Inc. Issues Allergy Alert On Undeclared Eggs In Pimento Spread Sandwiches (December 2)
Mom's Food Products, Inc. is recalling its Pimento Spread sandwiches with a expiration date of December 15th through the 18th due to the label not declaring an allergen egg yolks. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume these products.…
