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.

Recall Number: D-0009-2016

Firm: Apotex Inc.

Classification: Class II

Status: Terminated

Report Date: 20151021

Initiation Date: 20150825

Termination Date: 20220615

Lack of Assurance of Sterility: Failed preservative effectiveness testing

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.