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5/15/2002

Amgen Warns of Epogen Counterfeiting

Kate Traynor

Amgen Inc. announced last week that a counterfeit lot of the company's epoetin alfa product, Epogen, has surfaced in the United States.

The affected vials, labeled to contain 40,000 IU/mL of epoetin alfa and packaged in 10-vial cartons, bear the lot number P002970 and an expiration date of 7/03.

Update

05 June, 2002—Amgen Inc. recently identified two additional counterfeit lots of the company’s epoetin alfa product, Epogen. The affected lots are P001091, with an expiration date of 09/02, and P001486, with an expiration date of 12/02. As with the counterfeit material described by Amgen last month, the newly discovered vials are labeled as containing 40,000 U/mL of Epogen.

According to a press release issued by Amgen, the counterfeit vials hold a clear liquid containing epoetin alfa that has been diluted to a concentration of 2,000 IU/mL. The counterfeit material can be distinguished from the legitimate product in the following ways:

  • Genuine cartons of epoetin alfa are sealed with a plastic carton-closure label on which is printed an Amgen logo that appears blue when viewed from above but purple at eye level. The logo on carton-closure labels on the counterfeit product appears blue when viewed at any height.           
  • On counterfeit vials, two round "degree" symbols are missing from the section on the vial label that shows the proper storage temperature. The section simply states "Store at 2 to 8 C."

Jeff Richardson, Amgen's director of public relations, said the counterfeiting seems so far to be limited to "one location in one city." He said the company is not providing detailed information about the counterfeiting because it is the subject of an ongoing criminal investigation.

Amgen has asked pharmacists who believe they may have received counterfeit epoetin alfa to contact the Food and Drug Administration at 800-835-4709. The company has also advised customers to purchase the product only from authorized wholesalers that obtain the product directly from Amgen.