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FDAJanuary 5, 2016drug

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

Lack of Assurance of Sterility: Failed preservative effectiveness test

What to do

FDA enforcement status: Terminated

Brands named

mayne pharmamayne

UPCs

00378710935

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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