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Non-Safety, Voluntary Recall of H1N1 Flu Vaccine Issued

Approximately 800,000 pediatric doses recalled due to suspected efficacy issues

WEDNESDAY, Dec. 16 (HealthDay News) -- Approximately 800,000 pediatric doses of H1N1 influenza vaccine have been recalled by the manufacturer, Sanofi Pasteur, because of reduced potency, according to information provided Dec. 15 by federal officials.

On Dec. 7, the Centers for Disease Control and Prevention and the U.S. Food and Drug Administration were notified by the manufacturer of the vaccine that the potency in one batch of distributed pediatric syringes (referred to as a "lot") had subsequently dropped below a pre-specified limit. Upon further testing, the manufacturer discovered three additional distributed lots that, subsequent to distribution, later measured below pre-specified limits.

Instructions for returning any unused vaccine from these lots will be given to providers by the manufacturer. Federal officials have indicated that, even though the manufacturer is asking for return of any unused doses, safety of any utilized vaccine is not a concern at this time.

"All vaccines are routinely tested for purity, potency and safety prior to release," according to information posted online at "The four lots of vaccine met all required specifications at the time of release and shipment to distribution centers. The vaccine provided in multi-dose vials and the single-dose, 0.5 mL pre-filled syringes for persons 36 months and older continues to meet all specifications."

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