Par Pharmaceutical, Inc. Issues Voluntary Nationwide Recall of One Lot of Mycophenolate Mofetil for Injection

May 3, 2019

Endo International plc, announced today that one of its operating companies, Par Pharmaceutical, Inc., is voluntarily recalling one lot of Mycophenolate Mofetil for Injection, USP to the hospital and retail pharmacy level. 

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.

Read the complete FDA alert.