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Title: Three Lots of Imovax Rabies Pre-Exposure Vaccine Voluntarily Recalled
URL: http://www.pslgroup.com/dg/1DB13E.htm
Doctor's Guide
July 27, 2000


SWIFTWATER, PA -- July 27, 2000 -- 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. These individuals 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.

The vaccine being recalled is Imovax® Rabies ID, lot numbers P0313-3, P0030-2 and N1204-2. It is being recalled because results from routine stability testing conducted by the company detected that the potency of one lot had fallen below specification prior to the product's expiration date.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® 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.

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