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Manufacturer recalls human rabies vaccine

Infection Control Monitor, April 8, 2004

Vaccine maker Aventis Pasteur on April 2 recalled four lots of human rabies vaccine after discovering that the Imovax rabies vaccine contained live virus. Imovax is an inactivated viral vaccine and should not contain live virus.

The CDC and Food and Drug Administration (FDA) were recently notified that a quality-assurance test by the manufacturer identified the presence of noninactivated Pitman-Moore virus (the attenuated vaccine strain) in a single product lot. As a precautionary measure, Aventis Pasteur recalled lot numbers X0667-2, X0667-3, W1419-2, and W-1419-3, which were produced during the same period as the contaminated lot.

The 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. The test results show that any potential risk to those vaccinated with the recalled vaccine is likely to be low. No unusual adverse events associated with the recalled vaccine have been reported.

Aventis Pasteur said additional lots of recalled vaccine were distributed internationally. The company is working with regulatory authorities to determine lot numbers of the vaccine and countries that might have received recalled lots.

Healthcare providers should contact people who received recalled vaccine to follow recommendations from the CDC, which are available here. In addition, people who know they received rabies vaccine between September 23, 2003, and April 2 should contact their healthcare providers to determine whether they received recalled vaccine, and if so, whether they need further treatment.

Vaccine distributors and healthcare providers who have any remaining doses of the recalled lots should not use them and should contact Aventis Pasteur. Information about the recall is available from Aventis Pasteur at 800/835-3587 or at http://www.vaccineshoppe.com.

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