Recall of Antihemophilic Factor (Recombinant),
Helixate FS / Kogenate FS (Formulated with Sucrose)

DATE RECALL INITIATED:

January 9, 2002

PRODUCT / LOT NUMBER / EXPIRATION DATE:

Helixate FS       372J033C       9/4/2002
Kogenate FS     372J009A       3/30/2002 (This lot was distributed by Bayer in Canada)

MANUFACTURER:

Bayer Corporation
Berkley, CA

REASON:

Potency testing following nine weeks storage at room temperature found that the lots fell below the minimum potency specification. The lots continued to meet potency requirements when continuously refrigerated. The recall applies only to vials that were not stored under continuous refrigeration.

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.