FDA-Drug2016-01-27Class II
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
Mayne Pharma Usa
Hazard
Lack of Assurance of Sterility: Failed preservative effectiveness test
Sold states
Nationwide
Affected count
a) 52034 bottles and b) 22074 bottles
Manufactured in
1240 Sugg Pkwy, N/A, Greenville, NC, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0585-2016Don't want to check this manually?
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