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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Correction of Fluzone, Influenza Virus Vaccine, Single-Dose Vials

 

DATE CORRECTION INITIATED:   November 8, 2011

 
PRODUCT:
 
Fluzone, Influenza Virus Vaccine, Single-Dose Vials NDC 49281-011-10
 
MANUFACTURER:
 
Sanofi Pasteur, Inc.
Swiftwater, Pennsylvania
 
REASON:
 
Sanofi Pasteur is notifying customers of an error in the Prescribing Information (PI) that was included in packages of 10 single-dose vials of Fluzone vaccine (National Drug Code [NDC] 49281-011-10).
The third column header (labeled “Fluzone 0.5 mL Dose”) and fourth column header (labeled “Fluzone High-Dose 0.5 mL Dose”) in “Table 8: Fluzone, Fluzone High-Dose, and Fluzone Intradermal Ingredients” were inadvertently transposed, resulting in reversing the listings of ingredients and quantities per 0.5mL dose for Fluzone and Fluzone High-Dose vaccines. Please note that Fluzone vaccine contains 0.05% gelatin.
 
The PI that is the subject of this notification was only included in packages of 10 single-dose vials of Fluzone vaccine and has serial copy number 6044. The serial copy number can be found at the beginning and end of the PI. The PIs packaged with all other Fluzone vaccine presentations are not affected. If you have any packages containing the PI with serial number 6044, please discard the PI and refer to the correct PI. The vaccine does not need to be returned and may continue to be administered to patients per the label.
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The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.