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6/12/2002

Counterfeit Procrit Hits U.S. Market

Kate Traynor

Ortho Biotech Products L.P. announced late last week that two counterfeit lots of the company's epoetin alfa product, Procrit, have been discovered in the United States.
Update 18 October 2002—A third lot of counterfeit product has been found, according to Ortho. An online letter dated Oct. 11 states that packages labeled as Procrit 40,000 U/mL lot number P004582 actually contain 2,000 U/mL of the active ingredient. The letter includes photos of the authentic product and the counterfeit. Ortho said that, in the coming months, the cartons for all strengths of Procrit will have polychromatic seals that appear to change color when viewed from different angles. Health care professionals who suspect they received counterfeit vials should store them under the conditions stated in the legitimate labeling and call the Food and Drug Administration at 800-835-4709.

The counterfeit vials, which are labeled to contain 40,000 U/mL of epoetin alfa, instead contain active epoetin alfa at a concentration of 2,000 U/mL. A notice sent by Ortho to pharmacies and drug distributors speculated that the counterfeit material is authentic Procrit packaged in 2,000 U/mL vials that have been relabeled to resemble the more concentrated formulation.

According to Ortho, the counterfeit lot numbers—P002641, with an expiration date of September 2003, and P002384, with an expiration date of March 2003—are also found on legitimate vials of Procrit. The company said that "virtually all" authentic Procrit bearing these lot numbers is likely to have already been used by patients. Thus, Ortho warned health care professionals to treat as counterfeit any Procrit vials labeled with the two suspect lot numbers.

Photographs of authentic and counterfeit Procrit, and suggestions for identifying the counterfeit material, are available at the Ortho Web site. Ortho has asked health care professionnals who suspect they have counterfeit Procrit to telephone the Food and Drug Administration Center for Biologics Evaluation and Research at 800-835-4709.