Medical Advisory #425: Bayer Announces a Voluntary Recall of Two Lots of Kogenate FS

Bayer has announced a recall of two lots of Kogenate® FS 2000 IU vials. Within these two lots there were certain vials labeled as Kogenate FS but actually contain FVIII hemophilia A treatment, Jivi® antihemophilic factor (recombinant_ PEGylated-aucl 3000 IU. This recall is only in the United States where affected products were distributed. Below are the affected lots that were distributed from February 5, 2019 to July 15, 2019:

Patients in possession of any vials from either of these lots should immediately stop using the product and contact their physician and contact their product distributor or pharmacy to return the affected product. If a healthcare provider or patient has any questions they are encouraged to call Bayer’s medical communications hotline at 1-888-84-BAYER (1-888-842-2937).

Importantly, 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..

PHYSICIANS: Please distribute this information to all providers in your area who treat patients with hemophilia. 

CHAPTERS: Please distribute this information to your membership.

Please sign up for the Patient Notification System (PNS) to be notified directly about the latest recall or withdrawal of recombinant and plasma products. The system is confidential and time sensitive. It is administered by an independent third-party organization and is free of charge. To enroll in the PNS, please call (888) UPDATE-U or go online at http://www.patientnotificationsystem.org

This material is provided for your general information only. NHF does not give medical advice or engage in the practice of medicine. NHF under no circumstances recommends treatment for specific individuals and in all cases recommends that you consult your physician or local hemophilia treatment center before pursuing any course of treatment.