Recall of Two Lots of Bayer Kogenate® FS Antihemophilic Factor (Recombinant)
Bayer is voluntarily recalling two lots 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 U.S. is the only country where affected products were distributed. The manufacturer 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. The affected lots, distributed from February 5, 2019 to July 15, 2019 from Bayer’s distribution sites in Berkeley, CA and Shawnee, KS, are listed below:
- Kogenate FS antihemophilic factor (recombinant) 2000 IU
- NDC Number: 0026-3786-65; 0026-3786-65
- Product Code: DR03
- Lot Numbers: 27118RK; 27119CG
- Expiration: 06/12/2021
According to the recall notice, while the majority of the mislabeled vials in the affected lots were recovered, approximately 990 of these vials were released in the U.S. 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.
Bayer has voluntarily recalled 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. 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 without interruption. There are no lots of Jivi or Kovaltry® antihemophilic factor (recombinant) product affected by this recall.
Patients in possession of vials from the affected lot numbers should immediately stop using the product and contact their physician. In addition, patients should contact their pharmacy to return the affected product. Bayer is notifying its distributors in writing to check their stock immediately and to discontinue the distribution and use of any affected product. For distributors with questions regarding the recall process, please contact the Bayer Recall Coordinator, Inmar, at 855-707-7518.
See the recall notice for additional information.
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