Voluntary Recall of Kogenate® FS 2000 IU with Vial Adapter

Stability data indicate a decline in the potency outside of the pre-specified acceptable range for Kogenate FS 2000 IU.

Date: July 25, 2016

Please be advised that Bayer has issued a voluntary recall of Kogenate FS Antihemophilic Factor (Recombinant) 2000 IU. The material is packaged in 5 mL glass vials and comes in a shelf carton with either a BIO-SET or vial adapter.

According to Bayer, it is important to note that based on all currently available and reviewed data that no safety observations or signals have been detected by Bayer's drug safety group and the current health risk assessment does not indicate an appreciable risk for patients for the affected lots. 

Kogenate FS 2000 IU with Vial Adapter

Lot Number	Vial Size	NDC
270TN1C	1998 IU VL ADAPTER	00026-3786-65
270R978	1885 IU VL ADAPTER	00026-3786-65

Anyone with an existing inventory of Kogenate FS 2000 IU with vial adapter should determine whether they have product from the recalled lots, quarantine and discontinue distribution of this product.

Please return affected lot numbers of Kogenate FS 2000 IU with Vial Adapter to FFF and contact our Wow! Customer Care team to complete the RGA process.

If you had received notification and already returned the product to FFF, no action is required.

If you have any questions or need assistance, please call your FFF representative or Wow! Customer Care at (800) 843-7477.