Bayer is scrambling to get its hands on nearly 1,000 vials of one of its top-selling drugs after a labeling mishap led to them being filled with the wrong hemophilia medicines.
The German drugmaker is voluntarily recalling two consumer-level lots that are labeled as containing the hemophilia treatment Kogenate FS but that actually were filled with factor VIII hemophilia A treatment Jivi.
Bayer, which discovered the mislabeling last week, says all but 990 vials were caught before they made it into the marketplace. The company says it is watching for any adverse reports.
While Kogenate FS and Jivi are both meds to replace a missing clotting factor in people with hemophilia, Kogenate FS is approved to treat adults and children with hemophilia A while Jivi is approved for previously treated adults and adolescents who are at least 12 years of age.
“We understand that this news may be concerning for patients with hemophilia A who depend on these medicines,” the company said in a statement. “Bayer is committed to providing the most up-to-date and accurate information to those who may be affected by this issue. Bayer takes its 30-year partnership with the hemophilia community very seriously, and we remain deeply dedicated to meeting the needs of patients living with this life-long disease.”
The mislabeled meds were only released in the U.S. Patients with vials of Kogenate FS that do not come from the affected lot numbers, 27118RK and 27119CG, can use their drugs, as can anyone taking Jivi or Kovaltry, because those meds were unaffected by the problem.
Bayer says the Jivi batch expired in August 2018 but as of April still met all of its stability specs.
Jivi and Kogenate remain among Bayer’s top-selling drugs, turning in combined sales of $213 million in the first quarter.
Bayer last year had packaging issues in its consumer med side that resulted in a recall. It recalled an undisclosed number of packages of Alka-Seltzer, saying they might contain the wrong ingredients and could cause "serious health consequences."