Important Drug Information
Antihemophilic Factor (Human), Koate DVI
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.
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.