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FDANovember 10, 2023drug

Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25mg/mL), Ketorolac 0.5% (5mg/mL), 5 mL bottles, For Topical Ophthalmic Use Only, Not for IV Use, This is a Compounded Drug, Hospital & Office Use Only, Fagron Sterile Services, 8710 E 34th St N Wichita, KS 67226. NDC 7126...

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

The hazard

Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use syringe instead of a 5 mL dropper

What to do

FDA enforcement status: Ongoing

Brands named

fagron compounding servicesfagronfagron compounding

UPCs

71266824001

Recall history

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

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