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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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

DATE RECALL INITIATED:

May 30, 2006

PRODUCT / LOT NUMBER

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

RECALLING FIRM:

Amerisource Bergen
Chesterbrook, Pennsylvania

MANUFACTURER:

Sanofi Pasteur, Inc.
Swiftwater, Pennsylvania

REASON:

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
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448