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Vaccines, Blood & Biologics

Recall of Decavac Vaccine-Amerisource Bergen / Sanofi Pasteur, Inc.


May 30, 2006


Decavac Vaccine, 10 x 1, UD Syringe
NDC 49281-291-10
Lot Number - U1703AA


Amerisource Bergen
Chesterbrook, Pennsylvania


Sanofi Pasteur, Inc.
Swiftwater, Pennsylvania


Amerisource Bergen recently discovered that one carton of 300 packages of Decavac Vaccine (each package contains 10 single-dose syringes of the vaccine), from Lot Number U1703AA, exceeded labeled temperature requirements during shipment. The manufacturer of the vaccine, Sanofi Pasteur, has indicated that the vaccine's potency could be affected if not properly stored under manufacturer's requirements. Therefore anyone vaccinated with the affected vaccine should be re-vaccinated. This recall only affects 300 packages of vaccine from Lot Number U1703AA, which have been identified and accounted for by the distributor. Other vaccine from this lot is not affected and no other lot numbers are involved.

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

Page Last Updated: 06/27/2013
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