In Brief: Baxter Recombinate
Baxter Recombinate: Class I recall of recombinant human factor VIII for injection due to possible contamination with penicullium announced by FDA July 12. Baxter initiated recall when it found that four of 10,000 mock units in a "media fill" quality assurance test contained the mold. Lot numbers affected are 2938M228AA (976 IU per vial); 2938M229AA (291 IU per vial); and 2938M230 (1,130 IU per vial). Baxter expects about 3,000 vials to be returned...
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