Bayer Recalls Product Due to Mislabeling

July 29, 2019

Bayer is voluntarily recalling two lots of Kogenate FS antihemophilic factor (recombinant) 2000 IU vials because they contain the incorrect product.

Bayer announced on July 19, 2019 that it is voluntarily recalling two lots of Kogenate FS antihemophilic factor (recombinant) 2000 IU vials in the United States because certain vials that were labeled as Kogenate FS actually contain the FVIII hemophilia A treatment, Jivi antihemophilic factor (recombinant) PEGylated-aucl 3000 IU. Lots of Jivi or Kovaltry antihemophilic factor (recombinant) product have not been recalled.

Kogenate FS and Jivi are both used to replace clotting factor VIII or antihemophilic factor missing in people with hemophilia A. Kogenate FS is approved to treat or control bleeding in adults and children with hemophilia A. Jivi is approved to treat and control bleeding in previously treated adults and adolescents (12 years of age and older) with hemophilia A, according to the company.

The affected lots (27118RK and 27119CG, expiration 06/12/2021) were distributed from Feb. 5, 2019 to July 15, 2019. The company states the majority of the mislabeled vials in the affected lots were recovered, but approximately 990 of the vials were released in the US. Vials of Kogenate FS not associated with the affected lot numbers are not impacted by the recall.

“We understand that this news may be concerning for patients with hemophilia A who depend on these medicines. Bayer is committed to providing the most up-to-date and accurate information to those who may be affected by this issue. Bayer takes its 30-year partnership with the hemophilia community very seriously, and we remain deeply dedicated to meeting the needs of patients living with this life-long disease,” the company stated in an announcement.

The company is advising patients to stop using any vials from the affected lot numbers and contact their physician. Adverse events may be reported to FDA through its MedWatch program.

Source: FDA