Bayer voluntarily recalls two lots of Kogenate FS antihemophilic factor 2000 IU vials (recombinant) in the US, as certain vials labeled as Kogenate FS actually contained Jivi antihemophilic factor PEGylated-aucl 3000 IU (recombinant), a FVIII hemophilia A treatment.
Kogenate FS and Jivi are both medicines used to replace clotting factor (factor VIII or antihemophilic factor) that is missing in people with hemophilia A.
Kogenate FS and Jivi are both approved to treat or control bleeding in patients with hemophilia A. However, Jivi is approved for previously treated adults 12 years or older with hemophilia A, and Kogenate FS is approved for children and adults.
Approximately 990 of the vials were released in the US and the recall is limited to this country, with Bayer stating that most of the mislabeled vials had been recovered.
The lots were distributed between February 5, 2019, and July 15, 2019.