FLUVIRIN ® (Influenza Virus Vaccine) Luer-Lok pre-filled syringes
Novartis Vaccines and Diagnostics Limited
Liverpool United Kingdom
February 4, 2009
|Lot Number||Expiration Date|
|878771P||05 / 2009|
|878772P||05 / 2009|
|878773P||05 / 2009|
|878775P||05 / 2009|
|878776P||05 / 2009|
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:
Revaccination of patients that have been vaccinated with the affected lots is not necessary.
For additional information, please visit the FDA website at http://www.fda.gov/cber/recalls/novflu020409.htm or call the immunization program hotline 1-800-282-8672.