Non-safety related voluntary recall of certain lots of Sanofi Pasteur H1N1 pediatric (0.25 mL, for 6-35 month olds) vaccine in pre-filled syringes

Details

• Corporate Authors:
  Centers for Disease Control and Prevention (U.S.)
• Description:
  Tuesday, December 15, 2009, 10:05 EST (10:05 AM EST)
  
  CDCHAN-00303-2009-12-15-UPD-N
  
  Summary: As part of its quality assurance program, Sanofi Pasteur, Inc., performs additional routine, ongoing testing of influenza vaccines after the vaccine has been distributed to health care providers to ensure that vaccines continue to meet required specifications. In recent testing of the amount of antigen in its influenza A (H1N1) monovalent vaccine, Sanofi Pasteur found four distributed lots of single-dose, pre-filled syringe pediatric (0.25 mL.) vaccine with antigen content lower than required potency levels. The manufacturer is conducting a non-safety related voluntary recall of these affected lots of vaccine.
  
  
• Subjects:
  Child Drug Recalls Influenza, Human/prevention & Control Influenza A Virus, H1N1 Subtype Influenza Vaccines Syringes
• Source:
  HAN ; 303
• Series:
  Health Alert Network
• Document Type:
  HAN Health Update
• Place as Subject:
  United States
• Pages in Document:
  2 unnumbered pages
• Issue:
  303
• Collection(s):
  Health Alert Network (HAN)
• Main Document Checksum:
  urn:sha-512:3b77e913bef0b9dbed0f8df8b51e85518544aa62134f38b373243c59687c47591296b4beea29a13a00d047f5d8397814475bb17c00fb8c26edc24d8da4927cb8
• Download URL:
  https://stacks.cdc.gov/view/cdc/25214/cdc_25214_DS1.pdf
• File Type:
  [PDF - 1.27 MB ]