Last week, the FDA posted notice of what appeared to be a recall of Sanofi Pasteur’s FluZone. The notice indicated that the vaccine was misbranded “due to an error in the Prescribing Information (PI) included in packages of 10 single-dose vials of Fluzone vaccine”.
There has been some buzz about it online, so I reached out to my pediatrician for more information. Upon calling my pediatrician, I was informed that the recall was not in fact a recall but simply a notice sent to doctors of a reprinting of the package insert due to a transcription error on page 8 of the insert. The vaccine has not been recalled, and the recall notice does not impact the dosage, safety or effectiveness of the vaccine.
So if you or your child received the FluZone vaccine, rest assured that it has not been recalled.
The notice posted on the FDA’s recall page is reproduced below:
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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