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6/8/2001

More Counterfeit Neupogen Vials Found

Cheryl A. Thompson

For the third time this year, Amgen Inc. is reporting the existence of counterfeit Neupogen.

Lot number P000992 is the subject of the company's most recent announcement about the filgrastim product. Legitimate vials in this lot bear an expiration of "06/02"; counterfeit vials show "06/03."

In addition, the company suspects that there may be counterfeit vials of lot number P000905. Legitimate vials in this lot bear an expiration of "02/02"; counterfeit vials show "08/02."

Vials from lot numbers P000889 and P000819 are counterfeit. The company did not assign those lot numbers to the Neupogen product line.

The article below was posted on this Web page May 11, 2001.

Amgen Inc. announced yesterday that counterfeit drug products bearing the name Neupogen have been found in the U.S. drug supply.

This is the second time this year that the company's filgrastim product has been the subject of an effort to pass off a fake for the real thing.

The company advises pharmacies, physicians, and wholesalers to check their 300-microgram Neupogen vials for the following features:

  • Lot number (there is no lot P000948 in the Neupogen product line; for lot P000890, the correct expiration is "02/02"),     
  • Underside of vial stopper (should be flat),     
  • Vial height (should be about 34 mm),     
  • Patient insert (should be on thin, lightweight pale blue paper, have boxes around the drawings, and have the same orientation on the front and back),     
  • Health care professional's insert (should be on thin, lightweight paper measuring 16 inches by 24 inches when unfolded),     
  • Underside of flip-top closure (should be smooth, with an even metal edge),     
  • Top surface of stopper (should be indented),     
  • Label (font for product name should have a little space between the letters, lettering is crisp),     
  • Carton (font for lot number and expiration are rounder on authentic product), and     
  • Box (brand name is darker and bolder on authentic product, lettering is crisp).

Photographs of the authentic and counterfeit products can be viewed at the Amgen Web site.

Anyone who has a Neupogen-labeled vial and suspects it to be a counterfeit should call the Food and Drug Administration at 800-835-4709.