Medication Monitor

Generic Name (Trade Name—Company)
July 24, 2019

Antihemophilic factor

(Kogenate FS Antihemophilic Factor (Recombinant)—Bayer)
Bayer recalls two lots of Kogenate FS Antihemophilic Factor (Recombinant) in the United States

Bayer is voluntarily recalling two lots (27118RK and 27119CG) of Kogenate FS antihemophilic factor (recombinant) 2000 IU vials in the United States to the patient level. 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 affected lots were distributed from February 5, 2019, to July 15, 2019, from Bayer’s distribution sites in Berkeley, CA and Shawnee, KS.

While the majority of the mislabeled vials in the affected lots were recovered, approximately 990 of these vials were released in the United States. The associated Jivi batch was expired as of August 2018. However, all stability specifications of this expired Jivi batch had continued to be met as of April 2019.

The United States is the only country where affected products were distributed. Bayer said it is working closely with FDA to manage the recall and to minimize disruption to supply and inconvenience to patients.