Glass Fragment Prompts Recall of Immunosuppressive Agent

Par is recalling 1 lot of Mycophenolate Mofetil for Injection (lot# AD812; expiration date: 9/2020) following the discovery of a glass fragment within a reconstituted vial.

The product was distributed between January 23, 2019 and February 11, 2019 and is packaged in cartons of 4 single-use vials with NDC 42023-172-04. At this time, the Company has not received any reports of adverse events related to this recall.

Mycophenolate Mofetil for Injection, an immunosuppressive agent, is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. It should be used concomitantly with cyclosporine and corticosteroids.

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As the product is administered by intravenous infusion, the presence of a glass particulate may result in local irritation or swelling; serious adverse events may include blockage and clotting in blood vessels which could potentially be life-threatening.

Vials from the affected lot bear this label (credit: Endo Int.)

For more information call (800) 967-5952 (extension 1) or visit