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Author Archives: Food and Drug Administration--Recalls

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.