Denver Solutions, LLC DBA Leiters Health: Drug Recall

Recall #D-0288-2022 · 11/29/2021

Class II: Risk

Recall Details

Recall Number
D-0288-2022
Classification
Class II
Product Type
Drug
Recalling Firm
Denver Solutions, LLC DBA Leiters Health
Status
Terminated
Date Initiated
11/29/2021
Location
Englewood, CO, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1440 vials

Reason for Recall

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

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

Distribution Pattern

Nationwide within the United States

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.