Bayer Recalls Mislabeled Kogenate Vials Distributed in the U.S.

Bayer is recalling two lots of product vials that have been wrongly labeled as Kogenate FS antihemophilic factor (recombinant) 2000 IU, when in reality they contain Jivi antihemophilic factor (recombinant) PEGylated-aucl 3000 IU.

Both Kogenate (BAY14-2222) and Jivi (BAY 94-9027) are factor VIII replacement therapies that have been approved for the prophylactic (preventive) and on-demand treatment of patients with hemophilia A. Both medications work by providing the clotting factor VIII that patients with hemophilia A are missing, as a treatment and preventive measure to avoid spontaneous bleeding episodes. Kogenate is approved for adults and children, while Jivi is approved for previously treated adults and adolescents (12 and older) with hemophilia A.

According to information recently made public by the company, approximately 990 mislabeled vials (lots #27118RK and #27119CG) have been distributed in the U.S., more specifically in Berkely, California, and Shawnee, Kansas, between Feb. 5 and July 15, 2019.

Even though most of the mislabeled products have been recovered, Bayer is still working closely with the U.S. Food and Drug Administration (FDA) to recover the remaining vials and keep supply disruption and patient inconvenience to a minimum.

The company also has disclosed the expiration date of the mislabeled vials containing Jivi is actually August 2018, even though it stated that all stability specifications continued to be met as of April 2019.

“We have voluntarily recalled both lots in the interest of patient safety, and to ensure that any potentially impacted product is removed from pharmacy shelves, and that patients and their healthcare providers are alerted,” Bayer stated in an announcement.

Bayer also emphasized that any other vials of Kogenate distributed in the U.S. between February and July whose lot number does not correspond to any of the two affected lot numbers, may continue to be used without interruption. The company’s recall does not include any Jivi or Kovaltry (BAY 81-8973) product vials.

The company assures that patients’ safety is its top priority. The public announcement acknowledging product mislabeling was released as soon as the company identified the issue earlier in the same week. In the meantime the FDA also has been informed of the situation and is working diligently with the company to solve the issue as fast as possible.

Bayer is now urging that all patients who are in possession of the affected product vials to stop using them immediately and get in touch with their physician and pharmacy to return the mislabeled vials. In addition, the company has also contacted all product distributors to let them know they should check their stock and remove any affected product from circulation.

“We are carefully monitoring for any complaints or adverse event reports that may be related to this recall. We understand that this news may be concerning for patients with hemophilia A who depend on these medicines. Bayer is committed to providing the most up-to-date and accurate information to those who may be affected by this issue,” the company said.

Distributors who have questions regarding the recall process, should get in contact with Inmar, Bayer’s recall coordinator, at 855-707-7518. Patients and physicians who have questions should get in touch with the company’s medical communications hotline at 1-888-842-2937.