Vaccines, Blood & Biologics
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Recall of Typhim Vi, Typhoid Vi Polysaccharide Vaccine
DATE RECALL INITIATED: September 24, 2012
PRODUCT / LOT NUMBER / EXPIRATION DATE:
Prefilled syringes (NDCa 49281-790-51)
Lots:
E1287-1 (Expiration Date 20NOV12)
E1288-1 (Expiration Date 17NOV12)
G0481-1 (Expiration Date 07SEP13)
G0507-1 (Expiration Date 20SEP13)
G0508-1 (Expiration Date 27SEP13)
20-dose vials (NDC 49281-790-20)
Lot G1130-1 (Expiration Date 18MAR13)
MANUFACTURER:
Sanofi Pasteur SA
Marcy L’Etoile, France
REASON:
As a precautionary measure, Sanofi Pasteur is voluntarily recalling some lots of Typhim Vi vaccine (prefilled syringes and 20-dose vials). The vaccine met all release requirements at the time of distribution. Sanofi Pasteur is taking this action because these lots are at risk for lower antigen content. There is no safety concern related to this action. Sanofi Pasteur asks that you promptly examine your inventory. If you have any remaining doses from the above lots of the prefilled syringes or the 20-dose vials, PLEASE DO NOT USE THESE DOSES. Instructions for returning product are included in the Recall Notification.
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.
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