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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall of FLUVIRIN (Influenza Virus Vaccine) 2010-2011 Formula Multidose Vial

DATE RECALL INITIATED:

December 17, 2010

PRODUCT / LOT NUMBER:

FLUVIRIN (Influenza Virus Vaccine) 2010-2011 Formula Multidose Vials
Lot # 111812P1

MANUFACTURER:

Novartis Vaccines and Diagnostics, Inc.
Cambridge, MA 01239

REASON:

This recall of the above lot has been initiated because, for a small number of vials, cracked vial necks leading to broken vials have been detected. In addition, cracks in the vial necks carry the potential risk of product sterility being compromised, however Novartis Vaccines is not aware of any related safety issues being reported. For patients who have received vaccine from this affected lot within the past week, clinical assessment may be considered in accordance with routine medical judgment. Patients previously vaccinated with a dose from this lot who did not experience problems should be unaffected, and therefore no action, such as further clinical assessment or revaccination, is required.

Only FLUVIRIN multidose vials with the above specified lot number are subject to this recall; all other FLUVIRIN multidose vials and all FLUVIRIN prefilled syringes are unaffected and safe to use.

Consignees are asked to immediately check their inventory of FLUVIRIN multidose vials; refrain from using this product and return any vials from this lot obtain replacement product free of charge.


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.