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Swine Flu Vaccine Recalled for Potency Issues

Dec 16, 2009 | Parker Waichman LLP

About 800,000 doses of Sanofi Pasteur's swine flu vaccine meant for infants is being recalled, though health officials say they do not pose a safety risk.  According to the Centers for Disease Control (CDC), the recalled vaccine may lack potency. 

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):


0.25 ml pre-filled syringes, 25-packs (NDC # 49281-650-70, sometimes coded as 49281-0650-70):


The CDC said children who have received vaccine from the recalled lots will not need to be re-vaccinated because potency is only slightly below the “specified” range.  However, the agency is reminding parents and caregivers that all children less than 10 years old should get the recommended two doses of H1N1 vaccine approximately a month apart for the optimal immune response. Therefore, children less than 10 years old who have only received one dose of vaccine thus far should still receive a second dose of 2009 H1N1 vaccine.

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