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U.S. Department of Health and Human Services

Safety

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Procrit (epoetin alfa) June 2002

Audience: Oncologists and other healthcare professionals

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 lot number P002641 may have been used. However, pharmacists and health care providers should check the product lot number and carefully examine all vials of PROCRIT before use. A brief description of the differences between the actual product and the counterfeit are provided in the letter. (posted 6/11/2002, 2:30 pm EDT)

UPDATE: In addition to lot number P002641, lot number P002384, expiration: 03/2003 has also been determined to be counterfeit product. 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. (posted 6/11/2002, 3:40 pm EDT)

UPDATE 2: In a further update to the June 6, 2002 letter to healthcare professionals, additional counterfeit product labeled as PROCRIT has been found bearing lot number P004582, expiration 02/2004. Authentic PROCRIT, lot number P004582 with expiration date February 2004, was last shipped from the Ortho Biotech distribution center on July 1, 2002. Based on historical usage patterns and inventory practices, it is likely that virtually all authentic PROCRIT with lot number P004582, has already been used. Any product bearing this lot number should be considered suspect. (posted 10/22/2002, 9:00 am EDT)

[June 6, 2002 - Letter - Ortho Biotech] 
[June 7, 2002 - Update - Ortho Biotech]
[October 22, 2002 - Update - Ortho Biotech]