Recall of Decavac Vaccine

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.

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