Mayne Pharma Usa recalls Bromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and b) 5 mL bottles (NDC 00378-7109-35), Rx on
Recalled January 27, 2016 · FDA recall D-0585-2016 · Mayne Pharma Usa
Hazard
Lack of Assurance of Sterility: Failed preservative effectiveness test · FDA Class II
Units
a) 52034 bottles and b) 22074 bottles
Sold at
Nationwide
Description
Lack of Assurance of Sterility: Failed preservative effectiveness test
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
Manufacturer(s)
Mayne Pharma Usa
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →