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Notification - Biologic Recall Information


January 22, 2021

Notification - Biologic Recall Information

Initiated by : CSL Behring
Event Id :  194
Event Date :  01-22-2021

Therapy

Mononine®
NDC Number Lot Number Size Packaging Expiration Date
0053-6233-02 P100125501 1000 IU 08-28-2021

Reason

CSL Behring has initiated a Class II voluntary recall of one batch of Mononine due to a manufacturing deviation that occurred during the filling process.

Action

Pharmacies:
Immediately quarantine inventory of the affected product under your direct control and contact your supplier to arrange for return of the identified product.

Patients:
Patients are encouraged to contact their pharmacy regarding their individual prescription and to contact their physician about their treatment plan and potential alternative therapy options.

Other Information

This product recall is being conducted with the knowledge of the Food and Drug Administration.

For Medical Inquiries please contact CSL Behring Medical Information via phone at 1-800-504-5434 or via email at MedinfoNA@cslbehring.com.