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Sanofi Pasteur influenza A (H1N1) 2009 monovalent vaccine in multidose vials—shortened shelf life
  • Published Date:
    6/1/10
  • Source:
    HAN ; 317
  • Language:
    English
Filetype[PDF - 613.33 KB]


Details:
  • Corporate Authors:
    Centers for Disease Control and Prevention (U.S.) ; United States. Food and Drug Administration. ;
  • Series:
    HAN ; 317
  • Document Type:
  • Description:
    Friday, August 06, 2010, 17:00 EST (5:00 PM EST)

    CDCHAN -00317-2010-08-06-UPD-N

    Sanofi Pasteur has notified CDC and FDA that their influenza A (H1N1) 2009 monovalent vaccine manufactured in 2009 in multi-dose vials will have a shorter expiration period than indicated on the label, and they will provide more specific notification of which lots will be affected and the new expiration date in the very near future. This is to ensure that the vaccine is used while it remains within its potency specification. There are no safety concerns with these lots of 2009 H1N1 vaccine. People who were immunized with Sanofi Pasteur influenza A (H1N1) 2009 monovalent vaccine from multi-dose vials do not need to take any action.

  • Supporting Files:
    No Additional Files