CSL Behring L.L.C. has decided to initiate a voluntary recall of four lots of Monoclate-P, 1000 Unit. Vials from these four lots were distributed beginning on August 4, 2008.
This action is being taken with the knowledge of the United States Food and Drug Administration (FDA). These lots are being voluntarily recalled as a precautionary measure because they do not meet the potency specification when stored for three months at 5° C. No specific safety issues have been identified and neither have adverse incidents been reported. CSL Behring is requesting that the use of these lots be immediately discontinued and the product be returned to the company.
The following is a list of the recalled lots, with their respective expiration dates:
Pharmacies have been asked to immediately discontinue distribution and use of any on-hand stock from the recalled lots, and to return that stock to CSL Behring. Questions may be directed to CSL Customer Support at 1-800-683-1288.
Consumers with products from these lots should contact the home care company, 340B pharmacy, or specialty/mail order pharmacy that provided the product. Consumers with questions may also wish to contact their hemophilia treatment center (HTC).
PHYSICIANS: Please distribute this information to all providers in your area who treat patients with hemophilia.
CHAPTERS: Please distribute this information to your membership.
Please sign up for the Patient Notification System (PNS) to be notified directly about the latest recall or withdrawal of recombinant and plasma products. The System is confidential and time sensitive. It is administered by an independent third-party organization and is free of charge.
To enroll in the PNS, please go online at http://www.patientnotificationsystem.org