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FDA Recall Issued Over Bayer’s Mislabeled Kogenate FS

FDA Recall Issued Over Bayer’s Mislabeled Kogenate FS

This is not the first time the German biopharma giant stumbled over drug labeling

Update (July 31, 2019): The recall of Bayer’s life-saving hemophilia drug, Kogenate FS, has caught the attention of two organizations who represent and advocate for those suffering from the bleeding disorder. Last Friday, the National Hemophilia Foundation and the Hemophilia Federation of America submitted a joint letter to Bayer asking how the biopharma company planned to inform the hemophilia community about the recall. Both groups hope to continue discussions with Bayer and the FDA to learn how this serious event happened and what measures Bayer will take to ensure this doesn’t happen again.


Originally published on July 24, 2019:

Multinational pharmaceutical company Bayer has issued a voluntary recall of its hemophilia A drug, Kogenate FS, over a labeling mishap.

Two lots labeled as Kogenate FS actually contain a similar treatment called Jivi, a drug prescribed for the treatment of the same inherited bleeding disorder. While both drugs are used to replace clotting factor VIII, which is lacking in people with hemophilia A, Kogenate FS is intended to treat adults and children while Jivi is intended to treat adults and adolescents over 12 years old who have been previously treated.

Bayer had only discovered the mistake last week, but had successfully recovered “the majority” of these mislabeled vials. Approximately 990 vials were released in the US between February and July of this year, meaning many vials could still be sitting in pharmacy shelves or in patients’ homes.

The company is advising consumers who are in possession of these lots to stop using them immediately, return their vials to the pharmacist and contact their doctor.

“Importantly, vials of Kogenate FS that are not associated with the affected lot numbers (27118RK and 27119CG) are not impacted and can continue to be used without interruption,” reads the company’s statement.

Approximately 75 percent of the hemophilia community take a recombinant Factor VIII product, according to the National Hemophilia Foundation. The missing clotting factor causes people with this disease to bleed longer than normal, sometimes spontaneously in joints and muscles.

Bayer’s previous run-in with the packaging police took place last year, over Alka-Seltzer Plus tablets for the temporary relief of cold or flu symptoms. Non-matching ingredients listed on the front sticker, back of the carton and on the product itself led to the voluntary recall of Alka-Seltzer Plus, which was sold at certain US pharmacies and food stores.

Mislabeling can pose serious consequences for patients. At this time, no adverse events have been reported over the antihemophilic factor drug, but the company encourages patients and healthcare providers to submit their reports to the US Food and Drug Administration (FDA)’s MedWatch as they arise.