Bayer recalls two lots of mislabeled hemophilia A med

July 23, 2019

Bayer is voluntarily recalling two lots of Kogenate FS antihemophilic factor 2000 IU vials in the U.S. to the patient level. Vials from these two lots were labeled as Kogenate FS actually contained the FVIII hemophilia A treatment, Jivi antihemophilic factor PEGylated-aucl 3000 IU. The affected lots were distributed from February 5 to July 15 from Bayer’s distribution sites in Berkeley, CA and Shawnee, KS.

Approximately 990 of these vials were released in the U.S. The associated Jivi batch was expired as of August 2018. Bayer are voluntarily recalling both lots in the interest of patient safety, and to ensure that any potentially impacted product is removed from pharmacy shelves, and that patients and their healthcare providers are alerted.

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. 

Patients in possession of vials from the affected lot numbers should immediately stop using the product and contact their physician.

Read the recall statement.