FDA recall D-0536-2025

Imprimis NJOF, LLC · Class III · drug

Product

Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-733-05.

Reason for recall

Sub-Potent Drug: Subpotent assay results during stability testing.

Distribution

Nationwide in the USA

Key facts

Status: Completed
Initiation date: 2025-07-09
Report date: 2025-07-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Ledgewood, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0536-2025