DATE NOTIFICATION INITIATED:
October 3, 2019
PRODUCT / LOT NUMBER:
Humate-P [Antihemophilic Factor/von Willebrand Factor Complex (Human)]
Lots of All Fill Sizes (600, 1200, 2400 IUs) distributed by CSL Behring since February 2019
MANUFACTURER:
CSL Behring LLC Marburg, Germany
REASON:
CSL Behring LLC is alerting customers to a misalignment in the printing of the data on the folding box of Humate-P® [Antihemophilic Factor/von Willebrand Factor Complex (Human)] that might lead to confusion of the user.
On the folding box of Humate-P® the data for von Willebrand Factor Ristocetin Cofactor and Factor VIII potency, as well as expiry date and lot number are imprinted next to the preprinted text fields stating “VWF:RCo”, “FVIII”, “EXP” and “LOT”. Due to an error during packaging, the potency data was shifted downwards.
Representative sample of an affected lot
Representative sample of a non-affected lot
Although positioned incorrectly, the printed potency values on the folding box are correct.
Due to the incorrect positioning, the actual von Willebrand Factor (VWF:RCo) data could be mistaken as FVIII potency (FVIII) data.
As the data on all Humate-P® vial labels are positioned correctly and cannot be misinterpreted, CSL Behring asks that all users refer to the vial label for dosage calculations and follow instructions for use in the Prescribing Information.
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.
