Medical Advisory #422: Voluntary Recall Issued for Additional Lots of Recombinant Clotting Factor

Bayer has announced a voluntary recall on additional lots of Kogenate FS Antihemophilic Factor (Recombinant).  A prior voluntary recall for Kogenate FS was announced by the company on July 21, 2016. It was communicated by NHF in Medical Advisory #419.  As a result of an analysis conducted on additional lots manufactured before November 2015, a few additional lots are now being voluntarily recalled.

After routine stability testing, declining potency issues were the problem with these lots. The material is packaged in 5mL-glass vials and comes in a carton with either a BIO-SET or vial adapter.  The lots that fell below the “pre-specified” acceptable range were as follows:

In eight lots distributed between June 9, 2015, and August 2, 2016, potency may eventually fall below the “pre-specified” acceptable range before shelf-life expiration and are also subject to recall. These lots are listed here: 

Any product in your direct control should be immediately quarantined and pharmacies should be notified to remove these lots from their inventories. Any patients in possession of factor from these specific lots of Kogenate FS should return their inventory to the source from which they received their product.  Anyone with additional questions or concerns regarding these lots should speak with their product provider.

Based on all currently available and reviewed data accessible by Bayer, no safety observations or signals have been detected.  Further, the current health risk assessment does not indicate an appreciable risk for patients associated with the affected lots. 

If you have any questions related to replenishment, please call: 1.888.606.3780. For other inquiries, please call: 1.888.84.BAYER (1.888.842.2937).

The recent voluntary recall announcements made by CSL Behring and Bayer Corporation for their respective recombinant factor VIII products, Helixate FS and Kogenate FS, are not totally unrelated events. Bayer Corporation manufactures Kogenate FS at its facilities in Berkeley, California.  Under a long-standing agreement with CSL Behring, Bayer provides Kogenate FS to CSL, which then markets the product under the brand name Helixate FS.

PHYSICIANS: Please distribute this information to all providers in your area who treat patients with hemophilia. 

CHAPTERS: Please distribute this information to your membership.

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 for your general information only. NHF does not give medical advice or engage in the practice of medicine. NHF under no circumstances recommends 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.