Medical Advisory #421: Voluntary Recall Extension for Additional Lots of Helixate FS
CSL Behring has announced an extension to a voluntary recall of two lots of Helixate FS with vial adapter that was sent to the community in NHF Medical Advisory #420 on July 25, 2016. An analysis was conducted on additional lots manufactured before November 2015, prompting the recall of additional lots.
After routine stability testing, declining potency issues were the problem with these lots. Two lots that fell below the acceptable range were:
- Helixate FS 2000 IU Lot # 270PWG6 Expiry Date: 05/08/2017
- Helixate FS 1000 IU Lot # 270NV9G Expiry Date: 09/23/2016
Additional lots may eventually fall below the pre-specified acceptable range before shelf life expiration and may be subject to recall. These lots are listed on the following page of this document.
Based on all currently available and reviewed data accessible by CSL Behring, no safety relevant 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. Any patients with concerns regarding these lots should speak with their product provider.
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.