# FDA recall D-1050-2018

> **Lupin Pharmaceuticals Inc.** · Class III · drug recall initiated 2018-07-26.

## Product

Moxifloxacin Ophthalmic Solution USP, 0.5%,  5 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01

## Reason for recall

Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.

## Distribution

Product was distributed throughout the United States

## Key facts

- **Recall number:** D-1050-2018
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-07-26
- **Report date:** 2018-08-08
- **Termination date:** 2019-12-06

- **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-1050-2018

## Citation

> AI Analytics. FDA recall D-1050-2018. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/D-1050-2018. Source: US FDA. Licensed CC0.

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