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Voluntary Withdrawals of Helixate FS & Kogenate FS

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As part of HFA’s ongoing mission to assist and advocate for the bleeding disorders community, this medical news is being issued to keep you informed about product safety.

About These Withdrawals

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.

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.

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.

What are the lot numbers affected?

Product Name

Lot Number Expiration Date

Vial Size

Helixate FS 270R979 06/06/2018 2000 IU
Helixate FS 270TNIG 09/17/2017 2000 IU
Kogenate FS 270TNIC 06/06/2018 2000 IU
Kogenate FS 270R978 09/17/2017 2000 IU

Steps Those Impacted Should Take: 

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.

MORE ABOUT HELIXATE FS RECALL

MORE ABOUT KOGENATE FS RECALL

Where This Alert Came From

This post is not intended to make any medical claim. This withdrawal announcement was issued by Bayer Corporation and CSL Behring, and an alert was sent by Stericycle, Inc., managers of the Patient Notification System (PNS).

The PNS alerts registrants within 24 hours of a product recall or withdrawal. All manufacturers that currently have clotting factor products on the market are participating in this vital notification system reaching registered community members, physicians, nurses, and pharmacies.

This system is fast, free, and confidential.

About the Patient Notification System

Currently, fewer than 8,000 patients are enrolled in the PNS system (that's less than 40% of the bleeding disorders community)!  Are you signed up?

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The PNS is designed to alert patients within 24 hours of recalls that include:

  • Defective sterile water vials
  • Improperly packaged alcohol wipes
  • Problems with the product potency and shelf life
  • Mislabeled products
  • Factor contamination
  • And many more

Sign Up For PNS

If you have medical questions regarding this withdrawal, contact your physician.

For assistance regarding this recall, please call Stericycle, Inc., manager of the Patient Notification System, at 1-888-UPDATE-U (888-873-2838).

 

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Assisting and Advocating for the Bleeding Disorders Community