Amgen Recalls Products for Glass Flakes - Pharmaceutical Technology

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Amgen Recalls Products for Glass Flakes

ePT--the Electronic Newsletter of Pharmaceutical Technology

Amgen (Thousand Oaks, CA) issued a voluntary recall last week of certain lots of Epogen and Procrit (epoetin alfa) vials. The injectable products, used to treat anemia related to HIV therapy, chronic renal failure, and chemotherapy, may contain “extremely thin glass flakes (lamellae) that are barely visible,” says the press release. The lamellae, says the release, resulted from the interaction of the formulation with glass vials over the shelf life of the product. Approximately 200 lots of Epogen are being recalled, and 155 of Procrit are being recalled. Potential financial implications have not been released.

The company, along with Centocor Ortho Biotech Products, the authorized distributor of Procrit in the United States, found that the glass flakes have low potential for affecting patients. Although there have been no adverse event reports or complaints [as of Sept. 24, 2010], “potential serious adverse events resulting from the use of a sterile injectable product with particulates by the intravenous route include embolic, thrombotic, and other vascular events (e.g., phlebitis), and by the subcutaneous route include foreign body granuloma, local injection site reactions, and increased immunogenicity,” according to the Amgen release.

The recall is being conducted in cooperation with the US Food and Drug Administration. Of note, Amgen is the manufacturer of both Epoetin alfa products, which are manufactured in Puerto Rico, but Johnson & Johnson licenses and markets the product under the Procrit brand.


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