Bayer is voluntarily recalling two lots of Kogenate FS antihemophilic factor (recombinant) 2000 IU vials in the United States to the patient level, the company said Monday in a statement.
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. Bayer said it is working closely with the U.S. Food and Drug Administration to manage the recall and to minimize disruption to supply and inconvenience to patients.
Bayer said: “Patient safety is Bayer’s highest priority. We are carefully monitoring for any complaints or adverse event reports that may be related to this recall. The company is issuing this notification after discovering the issue earlier this week. Following an immediate internal assessment, Bayer contacted the FDA to inform the agency of the situation.“
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 is approved to treat or control bleeding in adults and children with hemophilia A. Jivi is approved to treat and control bleeding in previously treated adults and adolescents (12 years of age and older) with hemophilia A.