The Centers for Disease Control and Prevention has announced a voluntary recall of certain lots of the Sanofi Pasteur H1N1 pediatric vaccine in prefilled syringes shipped in November 2009. Approximately 800,000 vaccine doses in these lots are affected.
According to a statement issued by the CDC, Sanofi Pasteur Inc. distributed certain lots that contain antigen content below the specified limit for the product. The statement emphasized “that the small decrease in antigen content is unlikely to result in a clinically significant reduction in immune response among persons who have received the vaccine. For this reason there is no need to revaccinate persons who have received vaccine from these lots.”
The lots of concern, intended for children aged 6-35 months, are 0.25-mL prefilled syringes, 10-packs (NDC #49281-650-25, sometimes coded as 49281-0650-25): UT023DA, UT028DA, and UT028CB, as well as 0.25-mL prefilled syringes, 25-packs (NDC #49281-650-70, sometimes coded as 49281-0650-70): UT030CA.
Clinicians will receive instructions from Sanofi Pasteur regarding how to return unused vaccine from these lots, the statement said.
For more information about the recall, visit: www.cdc.gov/h1n1flu/vaccination/syringes_qa.htm