Medical Advisory: Bayer Announces Recall of Two Lots of Kogenate FS

Share on facebook
Share on google
Share on twitter
Share on linkedin
July 19, 2019 Bayer has announced a recall of two lots of Kogenate® FS 2000 IU vials.

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.

Share on facebook
Facebook
Share on google
Google+
Share on twitter
Twitter
Share on linkedin
LinkedIn

Leave a Reply

About Us

The Hemophilia Foundation of Michigan strives to improve the quality of life for all people affected by hemophilia, von Willebrand disease, other coagulation disorders, and related complications.

Recent Posts

It’s a Great Time to Review Your Insurance Plan for 2019

A few things to keep in mind! Do you depend on factor co-pay assistance? If so, you should know that some insurance plans have changed …

Read More →

What is an Accumulator Adjustment Program?

Beginning January 2018, a few health plans, specifically high deductible plans offered by self-insured employer groups, have changed the way they calculate copays for patients using these cards.

Read More →

Follow Us

Sign up for our Newsletter

Get all the latest updates and news from  HFM