Note: The following is the full text of an email communication received by HFA from Bayer HealthCare Pharmaceuticals:
Bayer in consultation with the FDA has voluntarily recalled approximately 300 vials (part of one lot) of Kogenate® FS, Antihemophilic Factor (Recombinant) in the U.S. as an excipient, used to stabilize the product during manufacturing, may not conform to the approved formulation. Bayer’s decision to voluntarily recall the product in question from distributors is a precautionary measure.
Patient safety is our highest priority, and we closely monitor for potential safety signals of all our products. We have no reason to believe that there is any patient safety risk related to this retail-level recall, based on the currently available information.
We are working closely with the FDA on this matter, and have reached out to our specialty pharmacy partners to ensure there is a process in place to notify any patients that received affected product. Bayer is committed to minimizing any potential disruption of product supply.