Recall D-0536-2025

US Class III Completed · initiated 2025-07-09

Recalling firm

Imprimis NJOF, LLC, NJ

Product

Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-733-05.

Reason for recall

Sub-Potent Drug: Subpotent assay results during stability testing.

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