Par Pharmaceutical, Inc. Recalls Mycophenolate Mofetil for Injection, USP

May 3, 2019
Pharmaceutical Technology Editors

The company is recalling one lot of Mycophenolate Mofetil for Injection, USP because of glass fragments found in a vial after reconstitution.

Endo International plc announced on May 1, 2019 that one of its operating companies, Par Pharmaceutical, Inc., is voluntarily recalling one lot of Mycophenolate Mofetil for Injection, USP. The recall was initiated after a glass fragment was found in one vial of product after reconstitution.

The recalled lot, AD812, expiry 09/2020, was manufactured for Par Pharmaceutical, Inc. by Gland Pharma Limited and distributed nationwide to wholesale distribution locations between Jan. 23 and Feb. 11, 2019. Mycophenolate Mofetil for Injection, USP is packaged in cartons of four single use vials with NDC 42023-172-04.

While the company has not received any reports of adverse events, it warns that administration of a glass particulate in an intravenous drug may result in local irritation, swelling, or more seriously, blockage and clotting in blood vessels. Adverse events may be reported to FDA via its MedWatch program.

Source: FDA