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Imprimis NJOF, LLC recalls MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% -

Recalled October 25, 2023 · FDA recall D-0043-2024 · Imprimis NJOF

Hazard
Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim. · FDA Class III
Units
6,228 bags + 15,360 boxes
Sold at
Product was distributed to physician's offices nationwide.

Description

Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.

Product
MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% - 0.5%, 5mL bottle, Imprimis, NJOF, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC:71384-632-05
Manufacturer(s)
Imprimis NJOF, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →

Imprimis NJOF, LLC recalls MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% - | RecallWatchUSA