Sanofi Recalls Certain Lots of H1N1 Vaccine

December 16, 2009

Sanofi Pasteur is recalling 4 lots of pediatric H1N1 vaccine in 0.25 mL pre-filled syringes because of concerns about potency.

Sanofi Pasteur is recalling 4 lots of pediatric H1N1 vaccine in 0.25 mL pre-filled syringes because of concerns about potency. Ongoing testing showed that the antigen content had decreased after these doses of vaccine had been shipped to providers.

The CDC emphasizes that there are no safety concerns with these lots of H1N1 vaccine. All successfully passed pre-release testing for purity, potency, and safety.

Children who received vaccine from these lots do not need to be revaccinated. The antigen is still expected to stimulate a protective response.

About 800,000 doses of vaccine in the 4 lots had been distributed. Sanofi Pasteur will notify providers who received these doses so that they can return any unused vaccine.

Vaccine doses with the following lot numbers are included in the recall:

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