Imprimis NJOF, LLC recalls Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15

Recalled April 9, 2025 · FDA recall D-0305-2025 · Imprimis NJOF

Hazard

Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim. · FDA Class III

Units

2822 bottles

Sold at

FL and NY

Description

Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.

Product

Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15 mL bottle, Imprimis NJOF, LLC, 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 →