UNITED STATES – As reported in an online news article published by www.wcjb.com and according to an FDA safety notification, Bayer has recalled 990 vials of a drug used to treat hemophilia after learning that these vials were mislabeled.
Bayer manufactures drugs used to treat patients with hemophilia A. The drugs replace a missing factor that causes hemophilia A, helping to prevent excessive bleeding. Bayer recently issued a recall of 990 vials of its hemophilia A drugs after discovering that these vials have been mislabeled. The specific drugs at issue are two lots of Kogenate FS antihemophilic factor (recombinant) 2000 IU vials. Instead of containing Kogenate FS, these 990 vials contained Bayer’s other hemophilia drug, Juvi.
Both Kogenate FS and Juvi are used to treat patients with hemophilia A who are missing clotting factor III (anti-hemophilic factor). Kogenate FS is approved to treat or control bleeding in adults and children with hemophilia A. Juvi is approved to manage or control bleeding in previously treated adults and adolescents (12 years of age and younger) with hemophilia A.
Specific Recall Information for Patients and Healthcare Providers
The Kogenate FS recall only affects patients in the United States. The mislabeled vials were not sold or distributed outside the United States. The mislabeled vials were distributed between February 5, 2019, and July 15, 2019. The specific product information provided by the Food and Drug Administration (FDA) for the recalled vials includes the following:
|Product Name||NDC Number||Product Code||Lot Number||Expiration Date|
|Kogenate FS antihemophilic factor (recombinant) 2000 IU||0026-3786-65||DR03||27118RK||06/12/2021|
The affected lots of the mislabeled Kogenate FS vials were distributed from Bayer locations in Berkeley, California and Shawnee, Kansas. Patients in possession of vials with the above-listed product information are instructed to stop using the product and contact their healthcare provider. Additionally, patients, pharmacies, and healthcare providers are encouraged to notify Bayer and the FDA of any adverse events associated with the two mislabeled lots of Kogenate FS.
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