Bayer Recalls Mislabeled Vials of Hemophilia A Treatment

Bayer is voluntarily recalling two lots of Kogenate FS antihemophilic factor (recombinant) 2000 IU vials in the US at the patient level due to mislabeling of certain vials. Certain vials from these two lots were labeled as Kogenate FS but actually contain the FVIII hemophilia A treatment, Jivi antihemophilic factor (recombinant) PEGylated-aucl 3000 IU.

The US is the only country where affected products were distributed. The affected lots were distributed from February 5, 2019 to July 5, 2019 from Bayer’s distribution sites in Berkeley, California and Shawnee, Kansas. While the majority of the mislabeled vials in the affected lots were recovered, approximately 990 of these vials were released in the US, according to Bayer.

Bayer says that the associated Jivi batch expired as of August 2018 and all stability specifications of this expired batch had continued to be met as of April 2019. Bayer says it has voluntarily recalled both lots in the interest of patient safety and to ensure that any potentially impacted product is removed from pharmacy shelves and that patients and their healthcare providers are alerted.

Vials of Kogenate FS that are not associated with the affected lot numbers are not impacted and can continue to be used without interruption, according to Bayer. There are no lots of Jivi or Kovaltry antihemophilic factor (recombinant) product affected by this recall, according to the company.

Kogenate FS and Jivi are medicines both used to replace clotting factor (factor VIII or antihemophilic factor) that is missing in people with hemophilia A.

Source: Bayer and US Food and Drug Administration

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