Recall of Antihemophilic Factor (Recombinant), Kogenate

DATE RECALL INITIATED:

March 28, 2002

LOT NUMBER / EXPIRATION DATE

670J039A 5/24/2002

MANUFACTURER:

Bayer Corporation
800 Dwight Way
Berkeley, CA 94701-198

REASON:

Bayer Corporation is recalling the above mentioned lot of Kogenate, Antihemophilic Factor (Recombinant) as a result of the product not meeting established product specifications. Through ongoing studies, Bayer Corporation determined that the recalled lot may not meet minimum potency requirements when stored over two months at room temperature conditions. Product that has been consistently stored under refrigeration or at room temperature for less than two months remains acceptable. .

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.