Voluntary Recall of Kcentra® 1000 IU Vial

March 23, 2018

Potential risk of breakage of the glass vials. There is an increased risk of breakage during transport and handling.

Please be advised that CSL Behring has issued a voluntary recall of Kcentra® 1000 IU vial.

According to CSL Behring, this recall has been initiated due to a potential risk of breakage of the glass vials with respect to the three (3) Kcentra® lots listed below, 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.

Kcentra® 1000 IU vial

Lot Number Vial Size Expiry Date
M9560111E 1000 IU VIAL 10/11/2020
N1260111A 1000 IU VIAL 10/27/2020
N1360111A 1000 IU VIAL 10/28/2020

Only the Kcentra® 1000 IU lots listed above are subject to this notification. All other lots on the market are unaffected and may continue to be used.

Anyone with an existing inventory of Kcentra® 1000 IU should determine whether they have product from the recalled lots, quarantine and discontinue distribution of this product.

If you have affected lot numbers of Kcentra® 1000 IU, please contact Wow! Customer Care to begin the returns process.

If you already received notification and returned the product to FFF Enterprises, no action is required.

For assistance, please call Wow! Customer Care at (800) 843-7477.