Bromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and b) 5 mL bottles (NDC 00378-7109-35), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505

Recall Number: D-0585-2016

Firm: Mayne Pharma Usa

Classification: Class II

Status: Terminated

Report Date: 20160127

Initiation Date: 20160105

Termination Date: 20170113

Lack of Assurance of Sterility: Failed preservative effectiveness test

Bromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and b) 5 mL bottles (NDC 00378-7109-35), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505