FDA recall D-0249-2026

Imprimis NJOF, LLC · Class II · drug

Product

Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, NJ 07852, NDC 71384-512-0.1

Reason for recall

Presence of particulate matter - Glass like particles.

Distribution

U.S Nationwide

Key facts

Status
Ongoing
Initiation date
2025-12-18
Report date
2026-01-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Ledgewood, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0249-2026