T97-30 Lawrence Bachorik: (301) 827-6242 July 12, 1997 Consumer Hotline: (800) 532-4440 RECOMBINANT HUMAN FACTOR VIII RECALLED BECAUSE OF POSSIBLE CONTAMINATION WITH MOLD The Food and Drug Administration (FDA) today announced that the Hyland Division of Baxter Healthcare is urgently recalling three lots of Recombinate, recombinant human Factor VIII, because of possible contamination with penicillium, a type of mold. Human Factor VIII is administered through intravenous injection. The possible contamination of Recombinate with mold presents the risk of infection and, in patients allergic to penicillin, the further risk of an allergic reaction. Because both risks could be severe and even life threatening, it is essential that hemophiliacs avoid using these lots of the product. The possible contamination with penicillium mold was found through quality control testing during manufacture. The lot numbers affected by this recall are as follows: Lot 2938M228AA -- 976 International Units (IU) per vial Lot 2938M229AA -- 291 IU per vial Lot 2938M230AA -- 1,130 IU per vial. Anyone who has these lots of Recombinate should return the product to the place where they obtained it. Patients and customers with questions may call the company at 1-800-423-2090. Human Factor VIII is used to treat hemophilia A, an inherited disorder in which the blood clotting protein Factor VIII is deficient or abnormal. Affected persons are unable to form blood clots normally and therefore risk serious and life- threatening bleeding episodes. Replacement therapy with Factor VIII corrects the defect temporarily, but must be given by intravenous infusion, in many cases daily or more often. Baxter is working to inform its customers, including distributors, physicians, and patients, about this recall. # # # #