Initiated by :  Bayer Corporation (US)
Event Id :  165
Event Date :  07-26-2016
KogenateŽ FS
NDC Number Lot Number Size Packaging Expiration Date
00026-3786-65 270TN1C 2000 IU Vial Adapter 06-06-2018
00026-3786-65 270R978 2000 IU Vial Adapter 09-17-2017
Reason Bayer is initiating a voluntary recall of two lots of its hemophilia A drug Kogenate FS containing active ingredient manufactured before November 2015. As part of our routine testing, stability data indicate a decline in potency outside of the pre-specified acceptable range for these lots, which is why the recall is being conducted. The material is packaged in 5ml glass vials and comes in a shelf carton with Vial Adapter.
Action Patients
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.

Immediately isolate inventory of the affected product under your direct control and contact your supplier to arrange for the return of the identified product.
Other Information This product withdrawal is being conducted with the knowledge of the Food and Drug Administration.
For Medical Inquiries, please contact Bayer Medical communications hotline at 1-888-84-BAYER (1-888-842-2937)