# FDA recall D-1848-2019

> **Mylan Pharmaceuticals Inc.** · Class III · drug recall initiated 2019-09-06.

## Product

Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for:  Mylan Pharmaceuticals Inc., Morgantown, WV 26505. Made in India. NDC: 0378-5431-35

## Reason for recall

Failed Impurities/Degradation Specifications:OOS for unknown impurity.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-1848-2019
- **Recalling firm:** Mylan Pharmaceuticals Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-09-06
- **Report date:** 2019-09-18
- **Termination date:** 2020-07-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morgantown, WV, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1848-2019

## Citation

> AI Analytics. FDA recall D-1848-2019. Retrieved 2026-07-05 from https://api.ai-analytics.org/recall/D-1848-2019. Source: US FDA. Licensed CC0.

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