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FDAJanuary 24, 2019drug

BromSite (bromfenac ophthalmic solution) 0.075%, 5 mL bottles, Rx Only, Distributed by : Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 49708-754-41

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

The hazard

Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.

What to do

FDA enforcement status: Terminated

Brands named

sun pharmaceuticalsun

Recall history

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

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