Class II recall: Mylan Pharmaceuticals Inc: Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4
The FDA classified a Class II recall for Mylan Pharmaceuticals' Mycophenolate Mofetil for Injection, USP, 500 mg/vial (NDC 67457-386-81 and 67457-386-00), citing failed dissolution specifications. The affected product includes cartons of 4 single-dose vials manufactured in India for Mylan Institutional LLC.
Most relevant for: Patients receiving intravenous mycophenolate mofetil, such as those unable to take oral formulations for immunosuppression in rheumatologic conditions.
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