SHARED BY THE NATIONAL HEMOPHILIA FOUNDATION
July 19, 2019 Bayer has announced a recall of two lots of Kogenate® FS 2000 IU vials. Within these two lots there were certain vials labeled as Kogenate FS but actually contain FVIII hemophilia A treatment, Jivi® antihemophilic factor (recombinant_ PEGylated-aucl 3000 IU. . This recall is only in the United States where affected products were distributed. Below are the affected lots that were distributed from February 5, 2019 to July 15, 2019:
Kogenate FS 2000 IU – Product Code DR03 – Lot # 27118RK – NDC # 0026-3786-65 – Epiry Date 6/12/2021
Kogenate FS 2000 IU – Product Code DR03 – Lot # 27119CG – NDC # 0026-3786-65– Epiry Date 6/12/2021
Patients in possession of any vials from either of these lots should immediately stop using the product and contact their physician and contact their product distributor or pharmacy to return the affected product. If a healthcare provider or patient has any questions they are encouraged to call Bayer’s medical communications hotline at 1-888-84-BAYER (1-888-842-2937).
Importantly, vials of Kogenate FS that are not associated with the affected lot numbers (27118RK and 27119CG) are not impacted and can continue to be used. 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
HFM DOES NOT OFFER MEDICAL ADVICE. Should you have questions regarding your treatment, please contact your medical provider. HFM does not endorse or recommend the use of a specific product or company and is sharing this for informational purposes only.