American Society of Hematology

Hematologic Drug Shortage Information


Updated on: August 24, 2016

ASH continues to work with Congress, federal agencies, and other stakeholders to ensure continued access to safe and effective hematologic drugs.

New Updates on Hematologic Drug Shortages

Bayer recalls Kogenate FS and CSL Behring recalls Helixate FS

 

Bayer and CSL Behring are initiating a voluntarily recalls of their hemophilia A drugs, Kogenate FS and Helixate FS (antihemophilic factor VIII [recombinant]). These drugs are being recalled because they containing active ingredients manufactured before November 2015. As part of the routine testing, stability data indicate a decline in potency outside of the pre-specified acceptable range for these lots. The material is packaged in 5mL glass vials and comes in a shelf carton. The Companies are asking customers to immediately quarantine inventory of the affected product under their direct control and to contact retail level customers to remove and return any affected inventory.

 For more information, please contact CSL Behring Medical Information at 1-800-504-5434 or Bayer at 1-800-288-8371. For more information or to notify ASH on other drug recalls or shortages, please contact Katherine Stark at kstark@hematology.org.

 

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Current Hematologic Drug Shortages

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Recently Resolved Hematologic Drug Shortages

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Additional Resources

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ASH's Comments to Congress and the U.S. Food and Drug Administration

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Media Coverage of Drug Shortages

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