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U.S. Department of Health and Human Services

For Consumers

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Important information about counterfeit PROCRIT (epoetin alfa) - Two lot numbers

6/12/2002

Ortho Biotech Products, L.P., with the knowledge of FDA, notified pharmacists, health care providers, and wholesalers/distributors of counterfeit PROCRIT (epoetin alfa). Vials of PROCRIT labeled as 40,000 U/mL in four-pack boxes, lot number P002641, expiration date: 9/03, have been found to contain active ingredient that is approximately 20 times lower than would be expected for PROCRIT in 40,000 U/mL vials. Based on inventory and historic use patterns it is thought that all existing inventory of AUTHENTIC lot number P002641 may have been used. Any product bearing this lot number should be considered suspect and be closely examined. A brief description of the differences between the actual product and the counterfeit, with comparative photographs, is provided in the Ortho Biotech letter.

In addition lot number P002384, expiration: 03/2003 has also been determined to be counterfeit. Distinctions between this counterfeit lot and authentic PROCRIT are still being analyzed. Distinctions may not be the same as those identified in the Dear Healthcare Professional letter dated June 6, 2002. Thus, any product bearing this lot number in particular should be considered suspect.

PROCRIT is used primarily for the treatment of anemia associated with chemotherapy, chronic renal failure (pre-dialysis), zidovudine treatment in HIV patients, and patients undergoing elective, noncardiac, nonvascular surgery.


June 6, 2002 Letter - http://www.fda.gov/medwatch/SAFETY/2002/procrit.htm
June 6, 2002 Letter - PDF format - ttp://www.fda.gov/medwatch/SAFETY/2002/ProcrittamperDDL.PDF


June 7, 2002 Letter - http://www.fda.gov/medwatch/SAFETY/2002/procrit2.htm
Ortho Biotech - PDF http://www.fda.gov/medwatch/SAFETY/2002/Procrittamper_UD.PDF

Richard Klein
Office of Special Health Issues
Food and Drug Administration