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U.S. Department of Health and Human Services

Safety

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Epogen (Epoetin alfa) May 2002

Audience: Pharmacists, distributors, and healthcare professionals

Amgen, with the knowledge of FDA, notified pharmacists and health care providers of counterfeit EPOGEN (epoetin alfa). EPOGEN 40,000 U/mL vials in ten-pack boxes, lot number P002970 expiration date: 7/03 has been found to contain active ingredient that is approximately 20 times lower than would be expected for EPOGEN in 40,000 U/mL vials. Pharmacists and health care providers should carefully examine all vials of EPOGEN before use. A brief description and pictures of the differences between the actual product and the counterfeit are provided.

[May 8, 2002 - Letter - Amgen]

Past MedWatch Alerts:
[Feb 2001 - Letter - Amgen]
[March 2000 - Letter - Amgen]