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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recovery Notice - Fluvirin (Influenza Virus Vaccine)-Novartis Vaccines and Diagnostics Limited/Cardinal Health Care

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.

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002