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Vaccines, Blood & Biologics

Important Drug Information - Antihemophilic Factor (Human), Koate DVI-Talecris Biotherapeutics

DATE NOTIFICATION INITIATED:

July 24, 2006

PRODUCT / LOT NUMBER / EXPIRATION DATE:

Lot Number: 26N7802
Expiration Date: 2/15/2008

MANUFACTURER:

Talecris Biotherapeutics
Clayton, NC

REASON:

Talecris Biotherapeutics issued an 'Important Drug Information' notification in reference to the carton label for one lot of Antihemophilic Factor (Human), Koate DVI. The product carton incorrectly states the amounts for certain product contents. The incorrect information resulted from a typesetting error that omitted the 'µ' symbol. This printing error affects only the product carton. The package insert included with each vial of product is accurate. No adverse events or labeling related complaints have been received for this lot. This product is suitable for continued use.

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(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

Page Last Updated: 06/27/2013
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