Recovery Notice
Fluvirin (Influenza Virus Vaccine)
DATE NOTICE INITIATED:
October 20, 2006
PRODUCT / LOT NUMBER / EXPIRATION DATE:
Fluvirin (Influenza Virus Vaccine)
NDC # 66521-109-10
Lot Number Expiration Date
71209 Jun 30 2007
71210 Jun 30 2007
MANUFACTURER:
Novartis Vaccines and Diagnostics Limited
Liverpool, United Kingdom
DISTRIBUTOR:
Cardinal Health Care
LaVergne, Tennessee
REASON:
Novartis recently became aware of some instances where Fluvirin shipped under the CDC contract was received from Cardinal Health Care, in either a frozen state and/or below the required storage temperature. Novartis is conducting a recovery of the shipments made under the CDC contract containing the above listed lots of Fluvirin Influenza Vaccine, which is in 5mL multi-dose vials bearing the Chiron Vaccines label. The shipments were distributed between October 11th and 17th, 2006.
The administration of Fluvirin that may have been frozen does not pose a risk to patient safety. However, it is Novartis' policy to advise healthcare professionals to advise patients to be re-immunized if they suspect that their vaccine has been frozen and therefore Novartis is taking this precautionary action.
Customers have been asked to contact the manufacturer to arrange for product return.
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.