FDA recalls 2.8 million Fluzone vaccines

http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm285791.htm
*PRODUCT*
Fluzone(R), Influenza Virus Vaccine, Single-Dose Vials, 0.5 mL, NDC
49281-011-10. Recall # B-0460-12
*CODE*
Lot numbers U4114DA, exp 6/30/12; U4118AA, exp 6/30/12; U4118BA, exp
6/30/12; U4118BB, exp 6/30/12; U4122AA, exp 6/30/12; U4122BA, exp
6/30/12; U4122CA, exp 6/30/12; U4124AA, exp 6/30/12; U4124BA, exp
6/30/12; U4124CA, exp 6/30/12; U4147AA, exp 6/30/12; U4147BA, exp
6/30/12; U4147CA, exp 6/30/12; U4149AA, exp 6/30/12; U4159DA, exp
6/30/12; U4178AA, exp 6/30/12; U4178BA, exp 6/30/12; U4184AA, exp
6/30/12; and U4197AB, exp 6/30/12
*RECALLING FIRM/MANUFACTURER*
Sanofi Pasteur, Inc., Swiftwater, PA, by letter on November 14, 2011.
Firm initiated recall is ongoing.
*REASON*
Fluzone(R), Influenza Virus Vaccine, Single-Dose Vials, 0.5mL,
misbranded due to an error in the Prescribing Information (PI) included
in packages of 10 single-dose vials of Fluzone vaccine, was distributed.
*VOLUME OF PRODUCT IN COMMERCE*
*2,832,810 units****
*DISTRIBUTION*
Nationwide
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