July 27, 2000Pre-Exposure Rabies Vaccine
Recalled by Aventis
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,
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
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.
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