Food and Drug Administration (FDA) - March 12, 2003
Richard Klein, Office of Special Health Issues

As part of the Food and Drug Administration's (FDA) ongoing efforts to investigate and address unscrupulous counterfeiting activities, FDA's Office of Criminal Investigation has uncovered the existence of contaminated counterfeit Procrit, also known as epoetin alfa. Procrit is used to stimulate the production of red blood cells in humans to treat severe anemia, and is indicated for some people with anemia related to treatment for HIV/AIDS.

As a result of investigative review and laboratory testing performed by FDA, and in cooperation with Ortho Biotech Products, L.P., Bridgewater, N.J., healthcare providers and consumers are being alerted to the existence of three lots of counterfeit product labeled as Procrit (epoetin alfa):

P007645 - 40,000 units/mL, Expiration 10-2004
P004677 - 40,000 units/mL, Expiration 02-2004
P004839 - 40,000 units/mL, Expiration 02-2004

The firm is issuing the warning to healthcare providers and others today in a letter (also posted on its website - see below) because counterfeit Procrit has been found to be contaminated with bacteria and therefore represents a significant potential hazard to consumers. In addition, FDA testing has demonstrated that some counterfeit product contains no active ingredient.

FDA urges health care providers and patients alike to check the packaging and vials very carefully before using this product. Anyone finding counterfeit product should not use it, should quarantine it, and should immediately contact FDA's Center for Biologics Evaluation and Research at 1-800-835-4709, prompt #1, then prompt #5, and Ortho Biotech at 1-800-325-7504, prompt #2.

In the performance of its responsibilities to assure the safety of products it regulates, FDA regularly conducts investigations and testing to identify and remove from the market counterfeit, tampered, or otherwise unsuitable products. FDA supports the activities of legitimate manufacturers, in cooperation with FDA, to inform the public about counterfeit products and how to identify them. FDA is committed to continued vigilance in rooting out counterfeiting activity and alerting the public to the existence of counterfeit product.

Physicians, pharmacists, nurses and patients should carefully examine all PROCRIT packaging and vials before use. Additional details concerning the counterfeit product, including identifying characteristics and photographs to help identify possible counterfeit product are available on Ortho's website at

http://www.procrit.com/counterfeit/letter.html

FDA's investigation into this matter is continuing.

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SOURCE: Food and Drug Administration (FDA).

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