Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/carton, Rx ...
FDA Recall #D-0288-2022 — Class II — November 29, 2021
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
Recalling Firm
Denver Solutions, LLC DBA Leiters Health — Englewood, CO
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1440 vials
Distribution
Nationwide within the United States
Code Information
Lot #: 2130958; Expiration Date 03/31/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated