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U.S. Department of Health and Human Services

Safety

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Epogen (epoetin alfa) Mar 2000

Health professionals/dialysis clinicians are notified of problems with multiple use of labeled single use Epogen vials. Amgen was made aware of 21 episodes of bacteremia or pyrogenic reactions in patients receiving Epogen at a U.S. dialysis unit. A Center for Disease Control and Prevention investigation revealed that unused portions of Epogen remaining in single dose preservative-free vials were collected and pooled into common vials for use in other patients. These practices were linked to extrinsic bacterial contamination of Epogen.

[March 24, 2000 - Letter - Amgen]