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Bayer Recalling 2 Lots of Mislabeled Kogenate FS Antihemophilic Factor

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Patients prescribed Kogenate FS antihemophilic factor (recombinant) 2000 IU vials by Bayer as well as medical professionals and pharmacies should take note of a July 19 recall issued on two lots of the clotting medication.

Only two lots of the 2000 IU vials distributed in the United States are impacted. They are:

  • NDC # 0026-3786-65, Product # DR03, Lot # 27118RK, Expiration Date 06/12/2021
  • NDC # 0026-3786-65, Product # DR03, Lot # 27119CG , Expiration Date 06/12/2021
Bayer is voluntarily recalling two lots of Kogenate FS antihemophilic factor (recombinant) 2000 IU vials distributed in the United States due to mislabeling.

Patients in possession of vials from the affected lot numbers should immediately stop using the product and contact their physician. In addition, patients should contact their pharmacy to return the affected product. 

Kogenate FS Antihemophilic Factor is used to replace clotting factor (factor VIII or antihemophilic factor) that is missing in people with hemophilia A. Kogenate FS is approved to treat or control bleeding in adults and children with hemophilia A. 

Certain vials from the two lots were labeled as Kogenate FS but actually contain the FVIII hemophilia A treatment, Jivi® antihemophilic factor (recombinant) PEGylated-aucl 3000 IU, Bayer noted in July 19 announcement about the recall. The majority of the vials have already been recovered, leaving only 990 vials unaccounted for.

“We are working closely with the U.S. Food and Drug Administration to manage the recall and to minimize disruption to supply and inconvenience to patients. The affected lots, distributed from February 5, 2019 to July 15, 2019 from Bayer’s distribution sites in Berkeley, CA and Shawnee, KS,” the company announcement states.

All other vials of Kogenate FS not associated with lot numbers 27118RK and 27119CG are not impacted and can continue to be used without interruption. No lots of Jivi or Kovaltry® antihemophilic factor (recombinant) product were affected by the recall, according to Bayer.

Distributors with questions regarding the recall process, may contact the Bayer Recall Coordinator, Inmar, at 855-707-7518.

Healthcare providers and patients may direct questions to Bayer’s medical communications hotline, 1-888-84-BAYER (1-888-842-2937).

Patients and healthcare providers are encouraged to report side effects or quality complaints of products to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088. For Bayer products, you can report these directly to Bayer at www.adversereactions.bayer.com.

Bayer is voluntarily recalling two lots of Kogenate FS antihemophilic factor (recombinant) 2000 IU vials distributed in the United States due to mislabeling.

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Author: Faith Huffman

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