Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Inj...
FDA Recall #D-0250-2026 — Class II — December 18, 2025
Product Description
Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01.
Reason for Recall
Presence of particulate matter - Glass like particles.
Recalling Firm
Imprimis NJOF, LLC — Ledgewood, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
596 boxes of 11,920 pre-filled syringes
Distribution
U.S Nationwide
Code Information
Lot: 25APR001A, 25APR001B, Expires: 04/03/2026.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated