Imprimis NJOF, LLC recalls Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per ca
Recalled July 30, 2025 · FDA recall D-0536-2025 · Imprimis NJOF
Hazard
Sub-Potent Drug: Subpotent assay results during stability testing. · FDA Class III
Units
2,890 vials
Sold at
Nationwide in the USA
Description
Sub-Potent Drug: Subpotent assay results during stability testing.
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.
Manufacturer(s)
Imprimis NJOF, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →