Certain Lots of Kcentra Recalled Due to Potential Risk of Vial Breakage

CSL Behring is recalling some batches of Kcentra 1000 U
CSL Behring is recalling some batches of Kcentra 1000 U

CSL Behring is recalling certain lots of Kcentra 1000 Units due to a potential risk of breakage of the glass vials during transport because of a change in the secondary packaging configuration. The lots involved in this recall include: M9560111E, N1260111A and N1360111A.

Kcentra, a prothrombin complex concentrate (human), is indicated for urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist therapy in adults with acute major bleeding or with need for an urgent surgery/invasive procedure. 

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The lots in question were packaged in January 2018, and distributed up until March 2018. Kcentra 500 Unit is not impacted by this recall. 

For more information visit FDA.gov.