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Affymax, Inc. (AFFY) Message Board

  • dinepat203 dinepat203 Feb 27, 2013 1:06 PM Flag

    FDA RECALL AMGN-EPOGEN IN 2010 -AMGN still $92

    Friday, September 24, 2010
    Amgen Recalls 200 Lots of Epogen and Procrit

    Certain lots of Epogen and Procrit (epoetin alfa) vials were voluntarily recalled by Amgen, as they may contain thin glass flakes, or lamellae, that result from the interaction of the formulation with glass vials over the shelf life of the product.

    To date, no complaints or adverse events have been reported that can directly be attributed to the presence of glass lamellae, Amgen said in a news release. Evaluations by Amgen and Centocor Ortho Biotech Products found a low potential of these glass flakes to affect patients.

    Potential serious adverse events resulting from the use of a sterile injectable product with particulates include embolic, thrombotic, and other vascular events (when the product is administered intravenously), and foreign body granuloma, local injection site reactions, and increased immunogenicity (when the product is administered subcutaneously).

    Both agents are manufactured in the United States by Amgen. Epogen also is sold in this country by Amgen, while Centocor Ortho Biotech Products is the authorized distributor of Procrit in the United States.

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