DATE RECALL INITIATED:
February 3, 2010
PRODUCT / LOT NUMBER / EXPIRATION DATE:
Influenza A (H1N1) 2009 Monovalent Vaccine in Prefilled Syringes
UT023AA, UT023BA, UT023CA, UT023EA, UT023FA
NDC # 49281-650-25, which also may be recorded as # 49281-0650-25, 0.25mL syringes in 10-packs
NDC # 49281-650-90, which also may be recorded as # 49281-0650-90, 0.5mL syringes in 25-packs
As part of an ongoing investigation into the stability of Influenza A (H1N1) 2009 Monovalent Vaccine in prefilled syringes, Sanofi Pasteur is recalling 6 additional lots becauseroutine testing found that the antigen content had declined below the specification limit. These lots passed all quality controls and met all specifications required by government agencies at the time of shipping.
This action is a continuation of activities that began in December 2009 with Sanofi Pasteur’s recall of 4 lots of pediatric H1N1 vaccine in prefilled syringes after routine stability testing determined that those lots no longer met the potency specification.
The U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC) have evaluated the data and agree that there are no safety issues and that individuals immunized with these lots do not need re-immunization. (Note: as routinely recommended, children under 10 years of age should receive their second immunization if they have not already done so.)
No action is needed other than to return unused doses from the recalled lots. Sanofi Pasteur is working closely with the FDA and the CDC to notify those who have administered the vaccine.
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.