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Medical Advisory #419: Voluntary Recall Issued for 2 Lots of Kogenate FS

July 25, 2016

Bayer has announced a voluntary recall of two lots of Kogenate FS with vial adapter. The two lots of 2,000 IUs contain active ingredient manufactured before November 2015. Recent stability testing revealed a loss of potency to below pre-specified acceptable levels. The lot numbers involved are:

  • Lot # 270TN1C
  • Lot # 270R978

This is not an issue of safety of the product. Any outstanding vials of these two lots will be replaced at no cost. For further information or to arrange for an exchange, please call the Recall Processing Center at 855-838-5782.

 

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.