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.
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.