Drug Safety Alerts

Kogenate® FS Patient-Level Recall

07/19/2019

On July 19, 2019, Bayer issued a patient-level recall of Kogenate^® FS NDC # 00026-3786-65. This recall was issued because, vials that were labeled as Kogenate FS actually contained FVIII hemophilia A, Jivi® antihemophilic factor (recombinant) PEGylated-aucl 3000 IU.

This could be a health hazard or safety risk to patients who may be using product affected by this recall.

This recall affects lot numbers 27118RK exp. 06/12/21 and 27119CG exp. 06/12/21. No other lots are affected by this recall. The affected lots went into distribution on February 5, 2019.

CVS Caremark^® Response: Please note that this product is not carried by the CVS Caremark Mail Service Pharmacies.

For more information about the voluntary Kogenate FS recall, please contact Bayer Medical Communications at 1-888-842-2937 or visit www.bayer.us. You may also contact the U.S. Food and Drug Administration (FDA) at 1-888-INFO-FDA (1-888-463-6332) or visit https://www.fda.gov.