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  5. Drug Recall: Kogenate FS antihemophilic factor (recombinant) 2000 IU
  1. Safety & Availability (Biologics)

Drug Recall: Kogenate FS antihemophilic factor (recombinant) 2000 IU

DATE RECALL INITIATED:

July 19, 2019

PRODUCT / LOT NUMBER / EXPIRATION DATE:

Kogenate FS antihemophilic factor (recombinant) 2000 IU

Lot Number Expiration Date
27118RK 6/12/2021
27119CG 6/12/2021

MANUFACTURER:

Bayer HealthCare LLC
Berkeley, California

REASON:

Bayer is voluntarily recalling two lots of Kogenate® FS antihemophilic factor (recombinant) 2000 IU vials in the United States to the patient level. Some vials from these two lots that were labeled as Kogenate FS actually contain the FVlll hemophilia A treatment, Jivi® antihemophilic factor (recombinant) PEGylated-aucl 3000 IU. The affected lots were distributed from Feb 5, 2019 to July 15, 2019 from their distribution sites in Berkeley, California and Shawnee, Kansas. Customers are asked to immediately quarantine inventory of the affected product and follow further instructions provided in Bayer’s Important Drug Recall notification.


The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.