# FDA recall D-1490-2019

> **Lupin Pharmaceuticals Inc.** · Class III · drug recall initiated 2019-07-11.

## Product

Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL Bottle, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC 68180-435-01.

## Reason for recall

Labeling: Missing label; Product complaints reported missing bottle label.

## Distribution

Nationwide in the U.S. and PR.

## Key facts

- **Recall number:** D-1490-2019
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-07-11
- **Report date:** 2019-07-24
- **Termination date:** 2020-09-09

- **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-1490-2019

## Citation

> AI Analytics. FDA recall D-1490-2019. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/D-1490-2019. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*