February 18, 2010
Sanofi Pasteur Inc. is initiating a non-safety related voluntary recall of six distributed lots of influenza A (H1N1) monovalent vaccine. Five affected lots are pediatric vaccines and one lot is for older children and adults. The potency of these pre-filled syringe vaccines was found to have dropped below pre-specified limits.

The recalled vaccines were distributed between November 2009 and January 2010. The affected lot numbers are: UT023AA, UT023BA, UT023CA, UT023EA, UT023FA (NDC #49281-650-25, 0.25 mL, in 10-packs) and UT037AA (NDC #49281-650-90, 0.5 mL, in 25-packs).

According to the Centers for Disease Control and Prevention (CDC), the lots met all required specifications at the time of release and there are no safety concerns for the people who have received vaccinations from affected lots. There is no need to revaccinate those who received these vaccines.

Vaccine providers should return any unused vaccine from the recalled lots to the manufacturer. For more information on returning unused vaccine, call the CDC, toll-free, at 800-232-4636.

For more information on this non-safety related recall, read the CDC health update.