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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Important Drug Information - Antihemophilic Factor (Human), Koate DVI (3 lots)-Talecris Biotherapeutics

DATE NOTIFICATION INITIATED:

July 24, 2006

PRODUCT / LOT NUMBER / EXPIRATION DATE:
Lot Number    Expiration Date

26N6XW1      11/29/2007
26N6N01       8/30/2007
26N7H01       3/31/2008

 

MANUFACTURER: 

Talecris Biotherapeutics
Clayton, NC

REASON:

Talecris Biotherapeutics issued an 'Important Drug Information' notification in reference to the carton label for three lots of Antihemophilic Factor (Human), Koate DVI. The product carton for the referenced lots incorrectly states the amounts for certain product contents. Specifically, the product carton states that the product contains not more than (NMT) 10 µg/mL aluminum. Each vial of Koate DVI actually contains NMT 1 µg/mL aluminum. This printing error affects only the product carton. The package insert included with each vial of the product is accurate. No adverse events or labeling related complaints have been received for these lots. The product is suitable for continued use.

 

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