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July 27, 2000

Pre-Exposure Rabies Vaccine Recalled by Aventis

Swiftwater, PA (SafetyAlerts) - Aventis Pasteur Inc.  announced today that, as a precautionary measure, they are voluntarily recalling three lots of a rabies vaccine that is used for pre-exposure immunization. This vaccine is used by individuals who are at high risk of exposure to rabies.  Individuals normally considered to be at high risk include veterinarians, animal handlers, spelunkers, certain laboratory workers as well as people traveling to other parts of the world where rabies is endemic.

This is not the same vaccine that is used when an individual is bitten by an animal suspected of carrying rabies.  No post-exposure vaccines are being recalled, and consumers who were vaccinated after a potential rabies exposure like an animal bite do not need to contact their doctors, Aventis said.

The vaccine being recalled is Imovax(R) Rabies ID, lot numbers P0313-3, P0030-2 and N1204-2. Only one lot was found to be sub-potent,  the other two related lots are being recalled as a precautionary measure.

Aventis Pasteur recommends that individuals who received pre-exposure immunization to rabies should contact their health care provider to determine if they should be re-immunized.

"There is no threat to health from receiving this vaccine. It is an issue of level of protection for individuals at high risk of exposure to rabies," said Frederick L. Ruben, M.D., Director, Scientific & Medical Affairs at Aventis Pasteur. "Because standard protocol for individuals who are exposed to rabies and who received pre-exposure immunization is for subsequent immunization with intramuscular (IM) rabies vaccine, we believe these individuals will develop sufficient antibodies for protection against disease even if they had been immunized with subpotent Imovax(R) Rabies ID."

The company is contacting all customers and distributors who received the recalled lots and will replace the vaccine at no charge to health care providers. The lots were first shipped in September 1998.

Notice of this product warning was sent via email to SafeMail subscribers July 27, 2000.

Selected Recent Recalls

Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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