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