Voluntary Recall of Helixate® FS 2000 IU

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

Date: July 25, 2016

Please be advised that CSL Behring has issued a voluntary recall of Helixate FS 2000 IU. The material is packaged in 5 mL glass vials and comes in a shelf carton with Sterile Water for Injection, USP, filter transfer set and package insert.

According to CSL Behring, 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. 

Helixate FS 2000 IU

Lot Number	Vial Size	NDC
270TN1G	1998 UNITS VIAL	00053-8134-02
270R979	1885 UNITS VIAL	00053-8134-02

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

Please return affected lot numbers of Helixate FS 2000 IU 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.