Apotex Inc. recalls Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-0595-05), b) 2.5 mL bottle (NDC 60505-0596-
Recalled October 21, 2015 · FDA recall D-0009-2016 · Apotex
Hazard
Lack of Assurance of Sterility: Failed preservative effectiveness testing · FDA Class II
Units
5,520 bottles (Lot MF0537), 2,828 bottles (Lot MF8090), and 20,454 bottles (Lot MF0532)
Sold at
Nationwide
Description
Lack of Assurance of Sterility: Failed preservative effectiveness testing
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.
Manufacturer(s)
Apotex Inc.
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →