Non-safety related recall of Sanofi Pasteur's H1N1 Pediatric vaccine

Sanofi Pasteur has issued a voluntary non-safety related recall of approximately 800,000 doses of its pediatric H1N1 vaccine in pre-filled syringes. The vaccine is being recalled after routine testing indicated that the potency in certain lots of pediatric syringes had fallen below the pre-specified limit. The lots being recalled had initially passed all quality controls and met all specifications prior to being shipped.

The following lots are being recalled:

  • 0.25 ml pre-filled syringes, 10-packs (NDC # 49281-650-25, sometimes coded as 49281-0650-25):Lot # UT023DA, UT028DA, UT028CB
  • 0.25 ml pre-filled syringes, 25-packs (NDC # 49281-650-70, sometimes coded as 49281-0650-70):Lot # UT030CA
The vaccine potency of these lots is only slightly below the “specified” range, and thus is still expected to be effective in stimulating a protective response despite the slight reduction in antigen concentration. Children who have received vaccines from these lots do not have to be revaccinated. However, it is recommended that all children <10yrs of age should receive the recommended two doses of H1N1 vaccine for optimal immune response.

For more information call (800) VACCINE or visit www.cdc.gov/h1n1flu/vaccination/syringes_qa.htm.