FDA recall D-0585-2016

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

Reason for recall

Lack of Assurance of Sterility: Failed preservative effectiveness test

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-01-05

Report date

2016-01-27

Termination date

2017-01-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Greenville, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0585-2016