---
title: "Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By:... — FDA record D-0637-2022 | Is It on Recall"
description: "Failed impurities/degradation specifications"
url: https://isitonrecall.com/recall/fda-drug-d-0637-2022-moxifloxacin-ophthalmic-solution-usp-0-5-3-ml-packaged-and-distributed-by-direct-rx-dawsonville-ga-3/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA drug enforcement

# Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Dist. B... — FDA record D-0637-2022

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Feb 17, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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**: Failed impurities/degradation specifications
- **Classification**: Class II
- **Recalling firm**: Direct Rx
- **Quantity**: 44 bottles
- **Agency-reported status**: Terminated
- **Source record identifier**: D-0637-2022

[Open the official record](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0637-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Lot#: 18JA2218 Exp. 6/30/23; 20DE2104 Exp. 6/30/23; 08NO2111 Exp. 6/30/23 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Florida

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Florida](https://isitonrecall.com/state/florida/)

## Dates in the source

- **Report date**: Mar 9, 2022
- **Recall initiation date**: Feb 17, 2022
- **Center classification date**: Feb 25, 2022
- **Termination date**: Oct 4, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0637-2022%22)

## Before changing a medicine

Follow urgent instructions in the current official recall notice. Speak to your pharmacist or prescriber before stopping or changing a prescribed medicine.

Talk to your doctor or pharmacist if you have questions or concerns about your medicine. [FDA medication recall guidance](https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do)

## Related records

[Medications records](https://isitonrecall.com/category/medications/) [Direct Rx records](https://isitonrecall.com/brand/direct-rx/)
