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2002 Safety Alert - Procrit (epoetin alfa)


This is the retyped text of a letter from Ortho Biotech Products, L.P. Contact the company for a copy of any referenced enclosures.


UPDATED INFORMATION
IMPORTANT DRUG WARNING


COUNTERFEITING OF PROCRIT®(Epoetin alfa)
June 7, 2002 ADDITIONAL COUNTERFEIT LOT


Ortho Biotech Products, L.P. is updating its information to physicians, pharmacies and wholesalers/distributors to report additional counterfeit PROCRIT (Epoetin alfa).
In addition to lot number P002641, discussed in the notice below dated June 6, 2002, the following lot number has also been determined to be counterfeit product.

PROCRIT® 40,000 U/mL
Lot Number: P002384
Expiration: 03/2003


Authentic PROCRIT, lot number P002384 with expiration date March 2003, was last shipped from the OBPLP distribution center on September 4, 2001. Based on historical usage patterns and inventory practices, it is likely that virtually all authentic PROCRIT with lot number P002384, already has been used. 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.
Physicians, pharmacists, nurses and all other healthcare professionals should carefully examine all PROCRIT packaging and vials before use.

If you receive any product that you suspect is counterfeit, do not use the product. Please quarantine and store the product under labeled conditions. Promptly contact the FDA at 1 (800) 835-4709, prompt #1, and then prompt #5 for further instructions. If you suspect that you may be in possession of counterfeit product labeled as PROCRIT, you should immediately contact your wholesaler/supplier regarding refund of the product.

Further updates will be posted on www.procrit.com and the United States link on www.orthobiotech.com as soon as new information becomes available.

Please refer to the June 6, 2002, Dear Healthcare Professional letter below for additional information.

Return to 2002 Safety Summary


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