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3/11/2003

Counterfeit Procrit Is Tainted, FDA Warns

Donna Young

Ortho Biotech Products L.P. issued a warning today about three contaminated counterfeit lots labeled as the company’s epoetin alfa product, Procrit.

The vials, which are labeled as containing 40,000 U/mL of epoetin alfa, have been found bearing lot numbers P007645, with an expiration date of October 2004; and lots P004677 and P004839, expiring February 2004.

Those lot numbers have been used by Ortho on authentic vials of epoetin alfa, according to the company.

Ortho sent a warning letter to health care providers alerting that testing, conducted by the Food and Drug Administration (FDA), indicated that possible contaminants in the counterfeit product include Acinetobacter and Pseudomonas spp.

According to Ortho, the counterfeit product appears as clear liquid, possibly water, with no active ingredient.

However, the company warned, it is likely that the counterfeit material was produced under nonsterile conditions and could pose a serious health risk to patients

To help pharmacists and other health care providers identify counterfeit vials labeled as epoetin alfa, Ortho has posted photographs and information on its Web site.

FDA erroneously used an incorrect lot number, P004389, in a statement posted on its Web site earlier today. The incorrect lot number was reported by the Associated Press in an article that was picked up by several news organizations.