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| |  Four Lots of H1N1 Vaccine Recalled, Revaccination Not Required ROCKVILLE, Md -- December 15, 2009 -- Sanofi Pasteur and the US Food and Drug Administration (FDA) are notifying healthcare professionals that 4 lots of influenza A(H1N1) vaccine are being recalled. The reason for the recall is not safety-related and is due to the fact that doses from these 4 vaccine lots no longer meet the manufacturer’s specifications for potency. Vaccine doses with the following lot numbers are included in the recall: Approximately 800,000 doses of vaccine in these lots were distributed to providers. Sanofi Pasteur will send providers directions for returning any unused vaccine from these lots. As part of its quality assurance program, Sanofi Pasteur performs routine, ongoing stability testing of its H1N1 vaccine after the vaccine has been shipped to providers. On December 7, Sanofi Pasteur notified the Centers for Disease Control and Prevention and the FDA that the potency in 1 lot of paediatric 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 3 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. There are no safety concerns with these lots of H1N1 vaccine. All lots successfully passed pre-release testing for purity, potency, and safety. Infants and children who received vaccines from these 4 lots do not need to be revaccinated. The vaccine potency is only slightly below the specified range. The vaccine in these lots is still expected to be effective in stimulating a protective response despite this slight reduction in the concentration of antigen.
SOURCE: US Food and Drug Administration
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