Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Recalled by Imprimis NJOF, LLC Due to Sub-Potent Drug: The stability batch showed a subpotent...

Date: February 24, 2025
Company: Imprimis NJOF, LLC
Status: Ongoing
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Imprimis NJOF, LLC directly.

Affected Products

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.

Quantity: 2822 bottles

Why Was This 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.

Where Was This Sold?

This product was distributed to 2 states: FL, NY

Affected (2 states)Not affected

About Imprimis NJOF, LLC

Imprimis NJOF, LLC has 21 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report