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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Important Notification: FLUVIRIN (Influenza Virus Vaccine) Luer-Lok pre-filled syringes - Novartis Vaccines and Diagnostics Limited

FLUVIRIN ® (Influenza Virus Vaccine) Luer-Lok pre-filled syringes

DATE NOTIFICATION INITIATED:

February 4, 2009

LOT NUMBER / EXPIRATION DATE:

Lot NumberExpiration Date
878771P05 / 2009
878772P05 / 2009
878773P05 / 2009
878775P05 / 2009
878776P05 / 2009

MANUFACTURER:

Novartis Vaccines and Diagnostics Limited
Liverpool United Kingdom

REASON:

Novartis Vaccines and Diagnostics Inc. has requested their customers to immediately discontinue use of and return any remaining doses they may have from five lots of FLUVIRIN® Influenza vaccine Luer-Lok pre-filled syringes.

Routine stability testing of FLUVIRIN in prefilled Luer-Lok syringes revealed a minor deviation in the potency of the A/Brisbane (H1N1) component of the vaccine. The vaccine met all required specifications at the time of release and has been monitored in monthly time intervals during its shelf life; it has consistently met specification until the most recent test point in early January 2009 that identified a minimal decrease in H1N1 antigen content.

The Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and Novartis Vaccines have agreed that no public health impact is expected because 1) all of the affected vaccine was shipped when the vaccine met potency requirements, 2) most influenza vaccine in the US is administered during October and November, months when the vaccine met potency requirements, and 3) the decrease in antigen content is small and would have a negligible if any effect on immune response to vaccination. Revaccination of patients that have been vaccinated with the affected lots is not necessary.

 

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Food and Drug Administration

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