2002 Safety Alert - Procrit (epoetin alfa) |
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.
HTML by JLW