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Non-safety-related voluntary recall of unused doses from certain lots of Sanofi Pasteu r H1N1 vaccine in pre-filled syringes
  • Published Date:
    1/29/10
  • Source:
    HAN ; 306
  • Language:
    English
Filetype[PDF - 624.97 KB]


Details:
  • Corporate Authors:
    Centers for Disease Control and Prevention (U.S.) ; United States. Food and Drug Administration. ;
  • Series:
    HAN ; 306
  • Document Type:
  • Description:
    Friday, January 29, 2010, 19:15 EST (7:15 PM EST)

    CDCHAN-00306-2010-01-29-UPD-N

    As part of its quality assurance program, Sanofi Pasteur, Inc., performs routine, ongoing testing of influenza vaccines after the vaccine has been distributed to health care providers to ensure that the vaccine continues to meet required specifications. In recent testing of its influenza A (H1N1) monovalent vaccine, Sanofi Pasteur found five distributed lots of single-dose, pre-filled syringe pediatric (0.25 mL) vaccine and one distributed lot of single-dose pre-filled syringe for older children and adults (0.5 mL) vaccine had potency below pre-specified limits. The manufacturer is conducting a non-safety related voluntary recall of any unused doses of these affected lots of vaccine. Information will be sent by Sanofi Pasteur to providers who received vaccine from the affected lots.

  • Supporting Files:
    No Additional Files