Recall of Two Lots of Bayer Kogenate® FS Antihemophilic Factor (Recombinant)

Published: 07/22/2019

  • Food and Drug Administration
Relevant To:
  • All Healthcare Organizations

Bayer is voluntarily recalling two lots of Kogenate® FS antihemophilic factor (recombinant) 2000 IU vials in the United States to the patient level. Certain vials from these two lots that were labeled as Kogenate FS actually contain the FVIII hemophilia A treatment, Jivi® antihemophilic factor (recombinant) PEGylated-aucl 3000 IU.

The U.S. is the only country where affected products were distributed. The manufacturer is working closely with the U.S. Food and Drug Administration to manage the r

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