Medical Advisory

Friday, August 12, 2016

Clarification of Voluntary Recalls Issued for Kogenate FS & Helixate FS

August 11, 2016

Upon clarification by the manufacturers of Kogenate FS (Bayer) and Helixate FS (CSL Behring), it has come to HFA's attention that ALL of the lot numbers listed below are included in the extension recalls issued on August 10, 2016 and the original recall notice of July 25, 2016.

This is not an issue of safety of the product. Routine stability testing showed potency is declining faster than expected in these lots, which is why the recall is being conducted. Product you may have from the these affected lots can be returned for replacement.

HFA encourages everyone to take action to be informed. Sign up for the Patient Notification System (PNS). If a therapy is withdrawn or recalled, the PNS system notifies those registered within 24 hours.

PNS is a fast, free, and confidential program that alerts patients with hemophilia, von Willebrand Disease, and other bleeding disorders of a withdrawal or recall of therapy products.  All major plasma-derived and recombinant analog therapy manufacturers participate in this system.

 

All Lot Numbers Affected by Recall

Listed by Product Name, Assay Size and Date of Recall Issued

  • Recall Initiated on July 21, 2016

  • Recall Extended on August 10, 2016

  • Recall Extended on August 10, 2016 (Clarification provided by manufacturers on August 12, 2016 that these lot numbers are INCLUDED in recall extension dated August 10, 2016)

BAYER: Kogenate FS


 Product

Lot Number

Expiration Date

Kogenate FS 250 IU Vial Adapter 270RV8X 12/19/2017
Kogenate FS 250 IU Vial Adapter 270TN10 06/04/2018
Kogenate FS 500 IU Vial Adapter 270R70V 08/27/2017
Kogenate FS 500 IU Vial Adapter 270RJ5L 11/23/2017
Kogenate FS 500 IU Vial Adapter 270T306 01/29/2018
Kogenate FS 500 IU Vial Adapter 270TG7L 03/25/2018
Kogenate FS 1000 IU Vial Adapter 270TW0R 07/08/2018
Kogenate FS 2000 IU Vial Adapter 270R978 09/17/2017
Kogenate FS 2000 IU Vial Adapter 270TN1C 06/06/2018
Kogenate FS 2000 IU Vial Adapter 270PWG8 05/08/2017
Kogenate FS 3000 IU Vial Adapter 270TTR6 06/22/2018
Kogenate FS 3000 IU Bio-Set 270NPV2 08/17/2016

This is not an issue of safety of the product. Routine stability testing showed potency is declining faster than expected in these lots, which is why the recall is being conducted. For further information or to arrange for an exchange, please contact Bayer at 1-888-84-BAYER (1-888-842-2937)

Bayer will be engaging the Patient Notification System (PNS) to notify all registrants and is notifying customers. For those of you signed up with PNS, you will receive additional notification from PNS/SteriCycle, Inc.

Click here for the full notification from Bayer.

 

CSL Behring: Helixate FS

Additional lots

https://www.hemophilia.org/sites/default/files/article/documents/CSL-Behring-Additional-Lots.pdf

It is important to note these are not FDA mandated recalls and should not be considered product safety issues.

 

PATIENT NOTIFICATION SYSTEM 

Please sign up for the Patient Notification System (PNS) to be notified directly about the latest recall or withdrawal of recombinant and plasma products. The system is confidential and time sensitive. It is administered by an independent third-party organization and is free of charge. To enroll in the PNS, please call (888) UPDATE-U or go online at http://www.patientnotificationsystem.org

 
This material is provided via HFA for your general information only. HFA and HFM do not give medical advice or engage in the practice of medicine. HFA and HFM under no circumstances recommend treatment for specific individuals and in all cases recommends that you consult your physician or local hemophilia treatment center before pursuing any course of treatment.


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