Two Lots of Kogenate FS Recalled
July 22, 2019 – Bayer has voluntarily recalled two lots of Kogenate® FS antihemophilic factor (recombinant) 2000 IU vials. Certain vials in the recalled lots were labeled as Kogenate FS though they actually contain Jivi® antihemophilic factor (recombinant) PEGylated-aucl 3000 IU.
The majority of the mislabeled vials in the affected lots have been recovered. However, Bayer has recalled both lots in the interest of patient safety. Vials of Kogenate FS that are not associated with the affected lot numbers (27118RK and 27119CG) are not impacted and can continue to be used. There are no lots of Jivi affected by this recall.
Kogenate FS and Jivi are both used to replace the clotting factor (factor VIII or antihemophilic factor) missing in individuals who have hemophilia A. Kogenate FS is approved to treat or control bleeding in adults and children, while Jivi is approved to treat and control bleeding in previously treated adults and adolescents (12 years of age and older).
Patients in possession of vials from the affected lots should stop using the product immediately and contact their healthcare provider. They should also contact their pharmacy to arrange a return of the recalled product. For questions regarding the recall, Bayer encourages patients and healthcare providers to contact their medical communications hotline at 1-888-84-BAYER (1-888-842-2937). Adverse events should be reported the U.S. FDA’s MedWatch program.
For additional information, please consult the full recall announcement at the FDA’s website.
BeneCard Central Fill has not dispensed any of the recalled product.