Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%,...
FDA Recall #D-0536-2025 — Class III — July 9, 2025
Product Description
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.
Recalling Firm
Imprimis NJOF, LLC — Ledgewood, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
2,890 vials
Distribution
Nationwide in the USA
Code Information
Lot: 25MAR032, Exp. 07/16/2025.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated