December 17, 2009
Sanofi Pasteur is conducting a non-safety-related voluntary recall of 4 lots of monovalent influenza A 2009 H1N1 vaccine because of a small decrease in antigen content found during ongoing testing routinely done after vaccine distribution. This voluntary recall applies only to Sanofi Pasteur's single-dose pediatric vaccine in pre-filled syringes.

According to the CDC, there (1) are no safety concerns with these lots and (2) no need to revaccinate children who have received vaccine from these lots since the small decrease in antigen content is unlikely to result in a clinically significant reduction in immune response.

Affected lots:

0.25 mL pre-filled syringes, 10-packs (NDC # 49281-650-25, sometimes coded as 49281-0650-25):

UT023DA
UT028DA
UT028CB

0.25 mL pre-filled syringes, 25-packs (NDC # 49281-650-70, sometimes coded as 49281-0650-70):

UT030CA

For more information and questions and answers related to the withdrawn vaccine please visit the CDC Web site.