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DATE RECALL INITIATED: July 28, 2000
LOT NUMBERS / EXPIRATION DATE:
P0313-3 04/16/2001
P0030-2 04/16/2001
N1204-2 02/27/2001
MANUFACTURER:
Aventis Pasteur S.A.
Lyon, France
DISTRIBUTOR:
Aventis Pasteur Inc.
Swiftwater, PA
REASON:
IMOVAX Rabies I.D. (Rabies Vaccine) is used for pre-exposure prophylaxis against rabies. In the course of routine stability testing, Aventis Pasteur learned that the potency of lot number P0313-3 had fallen below specification 24 months after manufacturing. Although this product met all specifications at the time of release, its potency fell below specification prior to the product's expiration date. Lot numbers P0030-2 and N1204-2 are also being recalled as a precautionary measure since all three lots were prepared from the same initial bulk lot.
The firm recommends, as a precaution, that patients who were vaccinated with one of these lots for pre-exposure prophylaxis---and who remain at risk for rabies exposure---should either be tested to measure the presence of antibodies and be vaccinated as needed (if the testing will not substantially delay vaccination), or be revaccinated.
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.
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