# FDA recall D-0646-2016

> **Bausch & Lomb, Inc.** · Class III · drug recall initiated 2016-01-18.

## Product

Tropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637. NDC: 24208-590-64.

## Reason for recall

Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.

## Distribution

U.S. Nationwide including Puerto Rico.

## Key facts

- **Recall number:** D-0646-2016
- **Recalling firm:** Bausch & Lomb, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-01-18
- **Report date:** 2016-02-03
- **Termination date:** 2020-01-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tampa, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0646-2016

## Citation

> AI Analytics. FDA recall D-0646-2016. Retrieved 2026-05-23 from https://api.ai-analytics.org/recall/D-0646-2016. Source: US FDA. Licensed CC0.

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