Recall of Antihemophilic Factor (Human), Koate-DVI

DATE RECALL INITIATED:

March 27, 2002

LOT NUMBER / EXPIRATION DATE

26N0078 9/26/2003
26N0075 9/26/2003

MANUFACTURER:

Bayer Corporation
79 T.W. Alexander Drive
4101 Research Commons
P.O. Box 13887
RTP, NC 27709

REASON:

Bayer Corporation is recalling Koate-DVI, Antihemophilic Factor (Human) after receiving information that a plasma unit used to manufacture one master lot of Koate-DVI had elevated levels of parvovirus B19 as measured by NAT (Nucleic Acid Testing). The one master lot was subdivided, for labeling purposes, into two lot numbers. A theoretical risk for transmission of parvovirus B19 exists in these two lots of Koate-DVI. .

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.