October 4, 1996

FDA has been receiving inquiries about the voluntary recall of one lot of Monoclate-P, an antihemophilic factor used to treat hemophilia A. The product is manufactured by Centeon L.L.C., King of Prussia, Pa., and may have been damaged as a result of a manufacturing problem creating a risk for contamination. Although no illnesses associated with this product lot have been reported to FDA, the lot has been recalled as a precautionary measure. The following may be used to answer questions.

The one lot of antihemophilic factor being recalled is Lot P72304, expiration date April 12, 1998.

Institutions or individuals possessing any vials of the recalled lot of Monoclate-P should return the product immediately to the manufacturer. The company's Customer Support telephone number is 1-800-683-1288. Health care professionals with questions may call the company's Medical Information Line at 1-800-504-5434.

FDA is asking health professionals to report any adverse events associated with Monoclate-P to MedWatch, FDA's adverse event reporting program, at 1-800-FDA-1088, and to the company.

Hemophilia A is an inherited disorder, sometimes called classic hemophilia, in which the blood clotting protein Factor VIII is deficient or abnormal. Affected persons are un able to form blood clots normally and therefore risk serious and life-threatening bleeding episodes. Replacement therapy with Factor VIII concentrate corrects the defect temporarily, but must be given by intravenous infusion, in many cases daily or more often.

On Sept. 23, 1996, Centeon recalled one lot of human albumin, Albuminar-25; on Oct. 3, 1996, nine additional lots were recalled. The albumin lots were recalled because of reports that linked one of the lots to septicemia, a systemic blood infection. Although it is believed that similar manufacturing problems may be related to both of Centeon's products, FDA has received no reports of illnesses related to Monoclate-P.

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