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

PUBLISHED: May 6, 2019
Relevant to: All Healthcare Organizations

Endo International plc, has announced 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. 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, Inc. has not received any reports of adverse events related to this recall.

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.

Par Pharmaceutical, Inc. is providing written notification to national wholesale accounts and direct customer locations that have received the affected lot and is arranging for return of all recalled product through Inmar, Inc. Wholesale distributors, retail pharmacies, and hospital pharmacies that have the product being recalled should immediately stop further distribution and use of vials from Lot AD812 and return any unused product by following the instructions in the recall notice.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program.

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