CSL Behring L.L.C. is initiating a field correction of component packs packaged with five specific lots of Mononine®. The packs do not have a complete seal between the soft blister pack and the package cover.
This action is being taken with the knowledge of the U.S. Food and Drug Administration (FDA). This is not a recall or withdrawal of the product itself—Mononine® therapy has not been compromised in any way. The product and its diluent are safe to use.
CSL is requesting that these lots of the component packs be immediately discontinued and returned to the company, where they will be exchanged for a completely sealed version. The five affected lots are listed in the accompanying letter from CSL Behring. Note: to qualify for the exchange, the following must correspond:Mononine® Lot Number, NDC Number and Component Pack Lot Number.
The following is a list of the five lots that should be exchanged, along with their respective expiration dates:
If you have questions, please contact CSL Customer Support: 1.800.683.1288.
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) for direct notifications about the latest recall or withdrawal of recombinant and plasma products. The system is free, confidential and time sensitive. It is administered by an independent third-party organization.
To enroll in PNS, please visit its website: http://www.patientnotificationsystem.org
