Par Pharmaceutical, Inc. Issues Voluntary Nationwide Recall of One Lot of Mycophenolate Mofetil for Injection, USP Due to the Presence of a Glass Fragment Observed in One Vial of Reconstituted Product
Summary
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. 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. Mycophenolate Mofetil for Injection, USP is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. 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. Vials from the affected lot bear this label: 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 below: Wholesalers, retailers, pharmacies, and consumers with questions regarding this recall can contact Inmar, Inc. either by phone at 1-800-967-5952, extension 1 (Monday through Friday between 9 am to 5 pm ET), or by email at .
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