Par Pharmaceutical Issues Recall of One Lot of Mycophenolate Mofetil for Injection

Endo International announced one of its operating companies, Par Pharmaceutical, is voluntarily recalling one lot of Mycophenolate Mofetil for Injection, USP to the hospital and retail pharmacy level. One vial of product was observed containing a glass fragment after reconstitution.

The administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening. To date, Par Pharmaceutical has not received any reports of adverse events related to this recall.

Mycophenolate Mofetil for Injection, USP is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. Mycophenolate Mofetil for Injection, USP should be used concomitantly with cyclosporine and corticosteroids. The affected Mycophenolate Mofetil for Injection, USP includes lot AD812, expiry 09/2020. The product, manufactured for Par Pharmaceutical, Inc. by Gland Pharma Limited, is packaged in cartons of 4 single use vials with NDC 42023-172-04. Mycophenolate Mofetil for Injection, USP, lot AD812 was distributed nationwide in the U.S. to wholesale distribution locations between January 23, 2019, and February 11, 2019.

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

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