PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: December 29, 2021 Initiated: November 29, 2021 #D-0288-2022

Product Description

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

Details

Units Affected
1440 vials
Distribution
Nationwide within the United States
Location
Englewood, CO

Frequently Asked Questions

What product was recalled?
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. Recalled by Denver Solutions, LLC DBA Leiters Health. Units affected: 1440 vials.
Why was this product recalled?
Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL
Which agency issued this recall?
This recall was issued by the FDA Drug on December 29, 2021. Severity: Moderate. Recall number: D-0288-2022.