National Joint Statement on Recall of Bayer Kogenate FS Lots

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Last week, Bayer announced the recall of two lots of Kogenate® FS antihemophilic factor (recombinant) 2000 IU vials. That highly concerning announcement has raised many questions on the part of both national organizations and community members.

Published July 26, 2019 on www.hemophilia.org

Last week, Bayer announced the recall of two lots of Kogenate® FS antihemophilic factor (recombinant) 2000 IU vials. That highly concerning announcement has raised many questions on the part of both national organizations and community members.

The fact that one product (Jivi), past its expiration date, was mislabeled as another product (Kogenate FS) and distributed to the public for six months is an event that should never have happened.

Today, HFA and NHF have submitted a letter to Bayer focusing on the company’s plans for accomplishing the recall, asking specifically:

  • How will Bayer notify patients of the recall
  • Where is all the recalled product now
  • How will the product be destroyed
  • How will Bayer communicate with the hemophilia community and with the FDA about this process

This is only the first step in what NHF and HFA expect to be continuing communications with Bayer and the FDA about how this serious event happened and how Bayer will ensure similar errors do not happen again. NHF and HFA’s priority today was to communicate to Bayer the need to expeditiously and thoroughly communicate to every patient impacted by this recall and learn more about Bayer’s plan to execute this recall.

This is an ongoing discussion and HFA and NHF will keep the bleeding disorders community informed as information is gathered.

 

*HFM has shared this information from the National Hemophilia Foundation.

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.

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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.

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