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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall of Rabies Vaccine (Human Diploid Cell), Imovax Rabies-Aventis Pasteur

DATE RECALL INITIATED:

 

April 2, 2004

 

LOT NUMBER / EXPIRATION DATE :

 

X0667-2 6/24/2006
X0667-3 6/24/2006
W1419-2 12/6/2005
W1419-3 12/6/2005

 

MANUFACTURER:

 

Aventis Pasteur
Swiftwater, PA

 

REASON:

 

Aventis Pasteur is recalling four lots of Imovax Rabies, Rabies Vaccine (Human Diploid Cell) that were distributed in the U.S. This is a precautionary measure stemming from the discovery through routine testing of a non-inactivated production strain of virus in a single product lot, which was not distributed. As a special safeguard, Aventis Pasteur initiated the voluntary recall in the U.S. and abroad of distributed rabies vaccine lots produced during the same time period. The lots being recalled passed all release tests, including testing to confirm the absence of live virus. The firm is requesting that the use of these lots be immediately discontinued and returned to the manufacturer.

 

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002