IMPORTANT: Voluntary Recall of Sanofi Pasteur H1N1 Vaccine Lot Numbers (posted:12/17/09)

Sanofi Pasteur, Inc., has notified the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) that routine testing of its pediatric H1N1 2009 monovalent vaccine in 0.25 ml syringes in four identified lots have been identified with lower antigen content than the specification limit.

The FDA and the CDC have determined there are no safety concerns with these lots of H1N1 vaccine. The vaccine in these lots is still expected to be effective in providing protection. Therefore, there is no need to re-administer a dose to those who received vaccine from these lots. However, as is recommended for all 2009 H1N1 vaccines, all children less than 10 years old should get the recommended two doses of H1N1 vaccine approximately one month apart for optimal protection.

The lot numbers affected by this recall are:

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

Providers should not use these affected lots. Follow the instructions in the attached document from Sanofi-Pasteur for returning the affected H1N1 vaccine using the postage-paid shipping label. Providers who have received H1N1 vaccine from the lots in question directly from McKesson will also receive a packet with instructions from Sanofi Pasteur. Sanofi Pasteur will ship their packets on Wednesday, December 16, 2009 for arrival on Thursday, December 17, 2009. All returns should be sent to: Capital Returns, 6101 North 64th Street, Milwaukee, WI 53218. Capital Returns is handling the return of affected vaccines for Sanofi Pasteur, they can be reached at 888-241-9288.