Notice to Readers: Voluntary Recall of
IMOVAX® Rabies I.D. (Rabies Vaccine) Used for Pre-Exposure Prophylaxis
Please note:
An
erratum has been published for this article. To view the erratum, please click here.
Through routine stability testing, Aventis Pasteur* recently learned that the
potency of one lot of IMOVAX® Rabies I.D. (Rabies Vaccine), used as an alternative to rabies
vaccine administered intramuscularly for pre-exposure prophylaxis, had fallen
below specification 24 months after manufacturing. Although this product met all
specifications at the time of release, its potency fell below specification before the product's
expiration date. Only lot P0313-2 was involved; however, lots P0030-2 and N1204-2 also are
being recalled as a precautionary measure. All three lots were prepared from the same
initial bulk lot.
To help ensure all persons who received a vaccination from one of the recalled
lots are alerted, the company is contacting all customers who received a shipment of
the
recalled lots. A toll-free telephone number also has been set up for medical
inquiries about the recall, (800) 752-9340. Persons who received pre-exposure vaccination
for rabies should contact their health-care provider to determine whether they should
be revaccinated.
As a precaution, 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. Aventis Pasteur recommends
that patients being revaccinated receive one dose of
IMOVAX® Rabies, Rabies Vaccine for intramuscular (IM) use.
* Use of trade names and commercial sources is for identification only and does not
constitute endorsement by CDC or the U.S. Department of Health and Human Services.
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