Institute of Good Manufacturing Practices India®

Vials for hemophilia treatment recalled by Bayer due to mislabeling

After the fear of mislabeled vials, Bayer has voluntarily recalled 2 lots of 2000 IU vials (recombinant) containing Kogenate FS antihemophilic factor in the United States. Even though the labels indicated Kogenate FS, some of those vials contained Jivi antihemophilic factor PEGylated-aucl 3000 IU (recombinant), used for treating FVⅢ hemophilia A.

Patients with hemophilia A lacks the clotting factor and both Kogenate and Jivi medicines are used to replace the clotting factor in such patients.

Kogenate FS was initially approved to treat or control bleeding in hemophilia A for children and adults. However, Jivi was meant for previously treated adults 12 years or older.

Bayer recalled approximately 990 vials that they released in the US market between February 5, 2019 and July 15, 2019.