# FDA recall D-0161-2020

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

## Product

Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to the Upper Eyelid, Sterile, a) 3 mL bottle NDC 0781-6206-93, b) 5 mL bottle NDC 0781-6206-75, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc., Princeton, NJ 08540, Product of Argentina.

## Reason for recall

Labeling: Incorrect or missing package insert.

## Distribution

Nationwide in the U.S.

## Key facts

- **Recall number:** D-0161-2020
- **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-0161-2020

## Citation

> AI Analytics. FDA recall D-0161-2020. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/D-0161-2020. Source: US FDA. Licensed CC0.

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