Product: 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
Reason for recall: Lack of Assurance of Sterility: Failed preservative effectiveness test
Recall initiated: 20160105
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated