FDA-Drug2021-12-29Class II

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

Denver Solutions, LLC DBA Leiters Health
Hazard

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

Sold states
Nationwide within the United States
Affected count
1440 vials
Manufactured in
13796 Compark Blvd, N/A, Englewood, CO, United States
Products
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

Official notice

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

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