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  1. Recalls (Biologics)

Urgent: Recall Notification Prothrombin Complex Concentrate (Human)

DATE RECALL INITIATED: 

March 22, 2018

PRODUCT / LOT NUMBER:

Prothrombin Complex Concentrate (Human)
Kcentra® 1000 U
Batch Numbers:  M9560111E,  N1260111A , N1360111A

MANUFACTURER: 

CSL Behring GmbH
Marburg, Germany

REASON:

CSL Behring is notifying customers of a potential risk of breakage of the glass vials with respect to the three (3) mentioned Kcentra lots, which were distributed until March 2018.  There is an increased risk of breakage during transport and handling of the product due to a change in the secondary packaging configuration in January 2018.

Only Kcentra 1000 U lots M9560111E, N1260111A and N1360111A are subject to this notification; all other lots on the market are unaffected and may continue to be used. 

Note:  Kcentra 500 U is not impacted.

CSL Behring GmbH is requesting that the use of the batches M9560111E, N1260111A and N1360111A  be immediately discontinued and the product be returned.


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.