United StatesMycophenolate Mofetil for injection, USP, 500 mg/vial—sterile single‑dose vials sold as cartons of 4 single‑dose vials (manufactured for Mylan Institutional LLC, NDCs 67457-386-81 and 67457-386-00), lots 3242616 (exp Apr 2027) and 8220216 (exp Nov 2027)—is being recalled. The product was recalled for failed dissolution specifications and the recall is ongoing; it was distributed nationwide in the United States.
What's being recalled
Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-81. Vial Label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, Single Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-00.
Recalling firm: Mylan Pharmaceuticals Inc, Morgantown, WV, United States.
How to identify it
Lot: 3242616, Exp. April 2027; 8220216, Exp. Nov 2027
The hazard
Failed Dissolution Specifications
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
U.S. Nationwide
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)