PlainRecalls
FDA Drug Moderate Class II Ongoing

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.

Reported: January 14, 2026 Initiated: December 18, 2025 #D-0250-2026

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.

Details

Recalling Firm
Imprimis NJOF, LLC
Units Affected
596 boxes of 11,920 pre-filled syringes
Distribution
U.S Nationwide
Location
Ledgewood, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by Imprimis NJOF, LLC. Units affected: 596 boxes of 11,920 pre-filled syringes.
Why was this product recalled?
Presence of particulate matter - Glass like particles.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 14, 2026. Severity: Moderate. Recall number: D-0250-2026.