Direct Rx: Drug Recall

Recall #D-0101-2023 · 11/02/2022

Class II: Risk

Recall Details

Recall Number: D-0101-2023
Classification: Class II
Product Type: Drug
Recalling Firm: Direct Rx
Status: Terminated
Date Initiated: 11/02/2022
Location: Dawsonville, GA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 11 bottles

Reason for Recall

cGMP deviation: discontinue of stability support for product.

Product Description

Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distributed By: Direct Rx, LLC 94 Worldwide Drive, Dawsonville, GA 30534, NDC 72189-0334-05

Distribution Pattern

Other Recalls by Direct Rx

Class II: Risk 03/07/2025

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II: Risk 03/07/2025

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II: Risk 01/31/2025

Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Class II: Risk 08/09/2024

Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Class II: Risk 03/22/2023

CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.

View all recalls by Direct Rx →

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.