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Manufacturer’s recall of human rabies vaccine
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04/02/2004
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Description:Friday, April 02, 2004, 23:11 EST (11:11 PM EST)
CDCHAN-00194-2004-04-02-ADV-N
CDC and the Food and Drug Administration (FDA) have been notified that a recent quality-assurance test of IMOVAX® Rabies Vaccine (Aventis Pasteur, Swiftwater, Pennsylvania) identified the presence of noninactivated Pitman-Moore virus (the attenuated vaccine strain) in a single product lot. IMOVAX® is an inactivated viral vaccine and should not contain live virus. The vaccine lot containing noninactivated virus was not distributed.
As a precautionary measure, Aventis Pasteur initiated a voluntary recall of lot numbers X0667-2, X0667-3, W1419-2, and W1419-3, which were produced during the same period as the lot that contained noninactivated Pitman-Moore virus. These four lots, which were distributed in the United States from September 23, 2003 through April 2, 2004, passed all FDA-approved release tests, including testing to confirm the absence of live virus. These test results suggest that any potential risk to those vaccinated with recalled vaccine is likely to be low. No unusual adverse events associated with the recalled vaccine have been reported.
The manufacturer has indicated that additional lots of recalled vaccine were distributed internationally. These lots also passed all release tests, including testing to confirm the absence of live virus. The manufacturer is working with regulatory authorities to determine lot numbers of vaccine and countries that might have received recalled lots. More information about these internationally distributed lots will be provided as it becomes available.
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