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Food and Drug Administration
U.S. Department of Health and Human Services
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FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. 

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.

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