Class IIIOngoing

Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5… recall

FDA recall D-0305-2025 · initiated Feb 24, 2025

Unlikely to cause harm but violates FDA labeling or manufacturing regulations.

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.

Details

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.
Recalling company: Imprimis NJOF, LLC
Classification: Class III
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: FL and NY
Initiated: Feb 24, 2025
FDA report date: Apr 9, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0305-2025 ↗

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