According to the Patient Notification System, CSL Behring has initiated a Voluntary Biological Product Recall for a single lot (#Y25709) of Mononine®, the company’s human plasma-derived factor therapy indicated for the prevention and control of bleeding in patients with hemophilia B. This voluntary action is being taken as a precautionary measure due to a manufacturing deviation during the filing process.
The recalled lot was distributed to the market in October 2018 and carries an expiration date of September 13, 2020. Y25709 is the only lot included in this recall, as all other Mononine® lots on the market are unaffected and may continue to be used. This recall, which is being conducted at the pharmacy level, is being conducted with the knowledge of the U.S. Food and Drug Administration. Inquiries should be directed to CSL Behring Medical Information at 1.800.504.5434 or to MedinfoNA@cslbehring.com.