FDA recall D-0288-2022

Denver Solutions, LLC DBA Leiters Health · Class II · drug

Product

Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/carton, Rx only, Leiters 13796 Compark Blvd, Englewood, CO 80112, (800) 292-6772, NDC 71449-096-42

Reason for recall

Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL

Distribution

Nationwide within the United States

Key facts

Status: Terminated
Initiation date: 2021-11-29
Report date: 2021-12-29
Termination date: 2022-07-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Englewood, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0288-2022