# FDA recall D-0163-2020

> **Sandoz Inc** · Class III · drug recall initiated 2019-10-17.

## Product

Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL bottle, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540, Product of India, NDC 61314-672-25.

## Reason for recall

Labeling: Incorrect or missing package insert.

## Distribution

Nationwide in the U.S.

## Key facts

- **Recall number:** D-0163-2020
- **Recalling firm:** Sandoz Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-10-17
- **Report date:** 2019-11-06
- **Termination date:** 2022-01-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0163-2020

## Citation

> AI Analytics. FDA recall D-0163-2020. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0163-2020. Source: US FDA. Licensed CC0.

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