Originally created 07/13/97

FDA recalls blood product treatment for hemophiliacs

WASHINGTON (AP) - Three lots of a blood product used to treat hemophiliacs are being recalled because of contamination with a potentially deadly mold.

The Food and Drug Administration said Saturday the Hyland Division of Baxter Healthcare recalled the medicine sold under the brand name Recombinate.

Recombinate is a brand of recombinant human Factor VIII, used to treat hemophilia A, an inherited disorder in which the blood clotting protein Factor VIII is abnormal. Patients, unable to form blood clots normally, risk life-threatening bleeding episodes.

Recombinate and Factor VIII products sold under other brand names are injected daily by 15,000 hemophilia A patients nationwide.

The three recalled batches of Recombinate are contaminated with penicillium, a type of mold, the FDA said.

The mold itself could cause an infection, and patients allergic to penicillin risk reaction because the mold contains the drug, the FDA said. Either result could be fatal.

The sizes and lot numbers of Recombinate affected by the recall are 976 international units per vial Lot 2938M228AA; 291 IU per vial Lot 2938M229AA; 1,130 IU per vial Lot 2938M230AA.

Customers with questions may call the company at 1-800-423-2090.


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