# FDA recall D-0517-2019

> **Lupin Pharmaceuticals Inc.** · Class III · drug recall initiated 2019-02-26.

## Product

Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01.

## Reason for recall

Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.

## Distribution

Nationwide in the USA and Puerto Rico.

## Key facts

- **Recall number:** D-0517-2019
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-02-26
- **Report date:** 2019-03-06
- **Termination date:** 2020-06-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Baltimore, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0517-2019

## Citation

> AI Analytics. FDA recall D-0517-2019. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0517-2019. Source: US FDA. Licensed CC0.

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