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2/20/2001

Epogen, Neupogen Vials Found Tampered

Cheryl A. Thompson

Amgen reports that eight vials of its epoetin alfa and filgrastim products have been found to contain counterfeit drug solution.

In a "Dear Health Care Provider" (PDF) letter dated Feb. 13, the manufacturer of Epogen and Neupogen stated that the vials' flip caps had been removed, the contents withdrawn and replaced with an aqueous solution (not always of the same volume as the original), and the caps replaced on the vials. The products were not used because, in each of the three incidents reported so far, someone noticed crusty white material around the vial stopper or particulates in the solution.

These reported tamperings involved Epogen lot numbers P000839 and P000841 and Neupogen lot numbers P00928 and P000698.

The company asks health care providers to advise patients who self-administer either product to carefully check their vials.

All irregularities with Epogen or Neupogen vials should be reported to Amgen at 800-772-6436. The company and the Food and Drug Administration are investigating the problem.