# FDA recall D-0484-2019

> **Lupin Pharmaceuticals Inc.** · Class III · drug recall initiated 2019-02-01.

## Product

Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL dropper bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 Manufactured by: lupin Limited Pithampur (M.P.) 454 775 India. NDC 68180-422-01

## Reason for recall

Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained.

## Distribution

Product was distributed by 5 wholesalers, 6 drug chains, 4 mail order pharmacies and 1 mail order pharmacy/supermarket who may have further distribute the product throughout the United States.

## Key facts

- **Recall number:** D-0484-2019
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-02-01
- **Report date:** 2019-02-20
- **Termination date:** 2020-06-26

- **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-0484-2019

## Citation

> AI Analytics. FDA recall D-0484-2019. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0484-2019. Source: US FDA. Licensed CC0.

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