BATON ROUGE, La. (WAFB) - Bayer is voluntarily recalling 990 vials of a biological drug used to help prevent and control serious bleeding in patients with hemophilia A.
The United States Food and Drug Administration (FDA) reported the July 19th recall for two lots of Kogenate(R) FS antihemophilic factor (recombinant) 2000 IU vials because of mislabeled vials.
The United States is the only country affected by the recall, and the mislabeled vials were distributed between Feb. 5, 2019, and July 15, 2019.
Kogenate FS and Jivi are both medicines used to replace clotting factor that is missing in people with hemophilia A.
Patients in possession of the mislabeled vials should stop using the product and contact their physician. The FDA also urges patients to contact their pharmacy to return the affected product.
Read the full recall notice here.
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