Recall: Vials Labeled as Kogenate FS Contain Another Hemophilia A Treatment

Bayer announced a voluntary recall of 2 lots of Kogenate FS antihemophilic factor (recombinant) 2000 IU vials that actually contain FVIII hemophilia A treatment, Jivi antihemophilic factor (recombinant) PEGylated-aucl 3000 IU.

The recalled Kogenate FS products, distributed from February 5, 2019 to July 15, 2019 from Bayer’s distribution sites in Berkeley, CA and Shawnee, KS, include:

• NDC Number: 0026-3786-65; Product Code: DR03; Lot Number: 27118RK; Exp Date: 6/12/2021
• NDC Number: 0026-3786-65; Product Code: DR03; Lot Number: 27119CG; Exp Date: 6/12/2021

Bayer has initiated the recall in the interest of patient safety; approximately 990 vials were affected by this recall although the majority have already been recovered. According to the company, stability specifications for the expired Jivi batch contained within the recalled vials continued to be met as of April 2019. 

Patients and healthcare providers may continue to use Kogenate FS vials that are not associated with the affected lot numbers; no lots of Jivi or Kovaltry antihemophilic factor products were affected by the recall.
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Kogenate FS is indicated for the prevention and control of hemorrhagic episodes in adults and children with hemophilia A. Jivi is indicated to treat and control bleeding in previously treated adults and adolescents (12 years of age and older) with hemophilia A.

For more information regarding this recall, contact Bayer by calling 1-888-842-2937.

Adverse events related to Bayer products can be reported by visiting the Bayer AE Reporting site.