Initiated by :  CSL Behring
Event Id :  164
Event Date :  07-25-2016
HelixateŽ FS
NDC Number Lot Number Size Packaging Expiration Date
00053-8134-02 270TN1G 2000 iu - 06-06-2018
00053-8134-02 270R979 2000 iu - 09-17-2017
Reason CSL Behring is initiating a voluntarily recall of two lots of its hemophilia A drug Helixate FS containing active ingredient manufactured before November 2015. As part of the 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 Sterile Water for Injection, USP, filter transfer set and package insert.
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 drug safety and the current health risk assessment does not indicate an appreciable risk for patients for the affected lots.

Immediately quarantine 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 Inquires please contact CSL Behring Medical Information at 1-800-504-5434.