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

Recall date

February 24, 2025

Source

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

Recall number

D-0305-2025

FDA classification

Class III

Brand / firm

Imprimis NJOF, LLC

Sold / distributed

FL and NY

Why it was recalled

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.

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%, 5 mL fill in 15 mL bottle, Imprimis NJOF, LLC, Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC: 71384-733-05.