# FDA recall D-0637-2022

> **Direct Rx** · Class II · drug recall initiated 2022-02-17.

## Product

Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Dist. By Aurobindo Pharma USA, Inc. East Windsor, NJ 08520, NDC 72189-076-05

## Reason for recall

Failed impurities/degradation specifications

## Distribution

Florida

## Key facts

- **Recall number:** D-0637-2022
- **Recalling firm:** Direct Rx
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-02-17
- **Report date:** 2022-03-09
- **Termination date:** 2023-10-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dawsonville, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0637-2022

## Citation

> AI Analytics. FDA recall D-0637-2022. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/D-0637-2022. Source: US FDA. Licensed CC0.

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