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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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