Voluntary Recall of Antihemophilic Factor (Recombinant), Helixate FS / Kogenate FS

DATE RECALL INITIATED:

September 12, 2001

PRODUCT / LOT NUMBER / EXPIRATION DATE:

Helixate FS 372J001C     12/15/2001
Helixate FS 372J023A     6/30/2002
Kogenate FS 372J009A     3/30/2002 (This lot was distributed by Bayer in Canada)

MANUFACTURER:

Bayer Corporation
Berkeley, CA

DISTRIBUTOR:

Aventis Behring
King of Prussia, PA

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.