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Notification - URGENT: Biologic Recall Information


June 7, 2019

Notification - URGENT Biologic Recall Information

Initiated by : CSL Behring
Event Id :  178
Event Date :  06-06-2019

Therapy

Mononine®
NDC Number Lot Number Size Packaging Expiration Date
0053-6233-02 Y25709 1000 IU 09-13-2020

Reason

CSL Behring is initiating a Voluntary Biological Product Recall as a precautionary measure for one lot of its Coagulation Factor IX (Human) Mononine®. NDC: 0053-6233-02

This lot is being voluntarily recalled as a precautionary measure due to a manufacturing deviation. CSL Behring made the decision to institute a voluntary recall, at the pharmacy level, to address the potential for a deviation during the filling process.

The recalled lot is Y25709 with an expiration date of 13 Sep 2020. Vials from this Mononine® lot were distributed to the market in October 2018.

Only the one mentioned lot is subject to this notification; all other Mononine® lots on the market are unaffected and may continue to be used. As agreed with the U.S. Food and Drug Administration (FDA), this recall is going to the pharmacy level.

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:
Contact your pharmacy to arrange return of the recalled lot.

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.