Product: Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-0595-05), b) 2.5 mL bottle (NDC 60505-0596-04), Rx Only, Mfg for: Apotex Corp., Weston, FL 33326.
Reason for recall: Lack of Assurance of Sterility: Failed preservative effectiveness testing
Recall initiated: 20150825
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated