Recall - Antihemophilic Factor, Human 

Date Notification Initiated: August 18, 2008
Product: 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 These lots are being withdrawn because they do not meet the potency specification when stored for three months at 5?C. CSL Behring is requesting that the use of these lots be immediately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.

Source: FDA


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