DATE RECALL INITIATED:
December 22, 2009
PRODUCT / LOT NUMBER / EXPIRATION DATE:
Package: Pre-filled sprayers
NDC: 66019-200-01 - Individual Sprayer
66019-200-05 - Tray of 5 syringes
66019-200-10 - Carton containing two trays of 5 syringes
500751P, 500754P, 500756P, 500757P, 500758P, 500759P, 500760P, 500761P, 500762P, 500763P, 500764P, 500765P, 500776P
Expiration Dates: January 19 – 26 2010
Stop distribution/administration of these lots immediately and return any inventory of these lots.
Routine stability testing of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal Lot 500751P revealed a slight decrease in the potency of the H1N1 component of the vaccine in early December. The vaccine met all required specifications at the time of release and has been monitored in weekly time intervals during its shelf life and has consistently met specification until the most recent test point in early December 2009. Lots 500754P, 500756P, 500757P, 500758P, 500759P, 500760P, 500761P and 500762P are expected to have the same slight decrease in potency as lot 500751. Additionally, data analysis suggests that four of the lots (500763P, 500764P, 500765P and 500776P) may expire before their labeled expiration dates and are being recalled as a precautionary measure. No other lots are being recalled.
The Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and MedImmune have agreed that no public health impact is expected because: 1) the decrease in potency is expected to have little if any impact on the response to vaccination and there are no safety concerns with these lots of vaccine, 2) all of the affected vaccine was shipped when the vaccine met potency requirements, and 3) most of the H1N1 influenza vaccine from these 13 lots was likely administered in October and November, during which the vaccine fully met potency requirements. In addition, 4 of the recalled lots (lots 500763P through 500776P) currently meet the specification for potency but are being recalled as a precaution because data analysis suggests the potency might decrease below specification before their labeled expiration dates.
Revaccination is not necessary since the slight decrease in potency is expected to have little if any impact on the response to vaccination.
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.