U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Vaccines, Blood & Biologics
  3. Safety & Availability (Biologics)
  4. Recalls (Biologics)
  5. 2019 Biologics Recalls
  1. Recalls (Biologics)

2019 Biologics Recalls

Date Notification Brand Name Product Description Reason/Problem Company
October 3, 2019 Important Drug Information - Humate-P [Antihemophilic Factor/von Willebrand Factor Complex (Human)] Lots of All Fill Sizes (600, 1200, 2400 IUs) distributed by CSL Behring since February 2019 CSL Behring LLC is alerting customers to a misalignment in the printing of the data on the folding box of Humate-P® [Antihemophilic Factor/von Willebrand Factor Complex (Human)] that might lead to confusion of the user. CSL Behring LLC
Marburg, Germany
July 19, 2019 Drug Recall: Kogenate FS antihemophilic factor (recombinant) 2000 IU Lot Number
27118RK
27119CG		 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. Bayer HealthCare LLC
Berkeley, California
Back to Top