800,000 Doses of Swine Flu Vaccine Recalled
There has been a recall issued for 800,000 doses of pediatric swine flu vaccine made by Sanofi Pasteur. According to the Centers for Disease Control (CDC), the recall is being issued because the vaccine may lack potency.
The recalled swine flu vaccine does not present a safety issue, the CDC said. The agency also 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.
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
On December 7, Sanofi Pasteur notified the CDC and FDA that the potency in one batch of pediatric syringes that had been distributed was later found to have dropped below a pre-specified limit. As a result of this finding, Sanofi Pasteur tested additional lots and found that three other lots that had been distributed also had an antigen content that, while properly filled at the time of manufacturing, was later measured to be below pre-specified limits. According to the CDC, this means that doses from these four vaccine lots no longer meet the manufacturer’s specifications for potency.
