Imprimis NJOF, LLC recalls Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per c…

Recall date

July 9, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0536-2025

FDA classification

Class III

Brand / firm

Imprimis NJOF, LLC

Sold / distributed

Nationwide in the USA

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.