FDA Recall D-0305-2025

Imprimis NJOF, LLC · Ledgewood, NJ

Class III Ongoing 444 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

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.

Lot / code: Lot 24OCT041, Exp 04/26/2025

Quantity: 2822 bottles

Reason for recall

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.

Recall record

Recall number: D-0305-2025
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Distribution: FL and NY
Recall initiated: 2025-02-24
Classified by FDA Center: 2025-03-28
FDA published: 2025-04-09
Recalling firm: Imprimis NJOF, LLC
Firm location: Ledgewood, NJ

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All recalls