Field Correction for Component Pack packaged with Mononine (Coagulation Factor IX, Human)-CSL Behring

DATE NOTIFICATION INITIATED:

August 18, 2008

PRODUCT / LOT NUMBER / EXPIRATION DATE:

Monoclate-P®, 1000 Unit Vials Antihemophilic Factor, Human

Lot Number: J91504, J91604, J91705 and J91806
Expiration Date: April 25, April 30, May 2 and June 9, 2010

MANUFACTURER:

CSL Behring L.L.C. Bradley, IL

REASON:

CSL Behring L.L.C. is initiating a Voluntary Recall of four lots of Monoclate-P®, Antihemophilic Factor, Human. These lots are being withdrawn because they do not meet the potency specification when stored for three months at 5ºC. CSL Behring is requesting that the use of these lots be immediately discontinued and the products be returned to the company. No adverse events or product complaints have been reported or associated with the use of this lot.