Medication Monitor

Generic Name (Trade Name—Company)
June 12, 2019

Mycophenolate mofetil for injection

(No trade name—Par Pharmaceutical)
Recalled product may contain glass particulate

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.

Administration of a glass particulate, if present in an I.V. 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. 

Mycophenolate mofetil for injection, USP, is indicated for prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac, or hepatic transplants. It should be used concomitantly with cyclosporine and corticosteroids.

The affected product includes lot AD812, expiry 09/2020. It is packaged in cartons of four single-use vials labeled NDC 42023-172-04 and was distributed nationwide in the United States between January 23, 2019, and February 11, 2019.

To date, Par Pharmaceutical has not received any reports of adverse events related to this recall.