Bayer is recalling two lots, or about 990 vials, of its biologic drug that helps prevent and control hemorrhagic episodes in patients with hemophilia A.
The affected product, Kogenate FS antihemophilic factor 2000 IU, was mislabeled. The vials instead contain Jivi, a different Hemophilia A drug.
The U.S. is the only country where affected products were distributed. The mislabeled vials were distributed between Feb. 5, 2019, and July 15, 2019.
"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. Bayer is notifying its distributors in writing to check their stock immediately and to discontinue the distribution and use of any affected product," the recall notice reads.
While both Jivi and Kogenate FS replace a clotting factor that is missing in people with hemophilia A, they contain different ingredients and are approved for different indications.
Access the full recall notice here.
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