# FDA recall D-0326-2022

> **Lupin Pharmaceuticals Inc.** · Class III · drug recall initiated 2021-12-22.

## Product

Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01.

## Reason for recall

Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.

## Distribution

Nationwide in the USA and Puerto Rico

## Key facts

- **Recall number:** D-0326-2022
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-12-22
- **Report date:** 2022-01-12
- **Termination date:** 2022-09-12

- **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-0326-2022

## Citation

> AI Analytics. FDA recall D-0326-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0326-2022. Source: US FDA. Licensed CC0.

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