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

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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

12/15/2009
By Centers for Disease Control and Prevention (U.S.)
Series: HAN ; 303

[PDF-1.27 MB]

English

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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
Series:

HAN ; 303
Document Type:

HAN Health Update
Place as Subject:

United States
Pages in Document:

2 unnumbered pages
Volume:

303
Collection(s):

Health Alert Network (HAN)
Main Document Checksum:

[+]

urn:sha-512:3b77e913bef0b9dbed0f8df8b51e85518544aa62134f38b373243c59687c47591296b4beea29a13a00d047f5d8397814475bb17c00fb8c26edc24d8da4927cb8
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https://stacks.cdc.gov/view/cdc/25214/cdc_25214_DS1.pdf
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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

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