AAP News Vol. 13 No. 8 August 1997, p. 13
© 1997 American Academy of Pediatrics
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Recombinant human Factor VIII recalled

The Food and Drug Administration (FDA) has issued an "urgent recall" of three lots of RecombinateTM — recombinant human Factor VIII — because of possible contamination with Penicillium, a type of mold.

Human Factor VIII, used to treat hemophilia, is administered by intravenous injection. Possible contamination with mold presents the risk of infection. Patients allergic to penicillin also are at risk of an allergic reaction. Because both risks could be severe and life threatening, it is essential that hemophiliacs avoid using the following lots of Recombinate:

Lot 2938M228AA — Potency/vial: 976 International Units (IU)

Lot 2938M229AA — Potency/vial: 291 IU

Lot 2938M230AA — Potency/vial: 1,130 IU

The recall is reported to affect 5,324 vials of Recombinate widely distributed throughout the United States June 17 to July 10, 1997.