# FDA recall D-0146-2018

> **Taro Pharmaceuticals U.S.A., Inc.** · Class III · drug recall initiated 2017-09-20.

## Product

Fluocinonide Gel USP, 0.05%, 15 g tube, Rx Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton Ontario Canada  L6T1C1, Dist. by: Taro Pharmaceuticals U.S.A . Inc. Hawthorne NY 10532, NDC 51672-1279-1

## Reason for recall

Cross contamination with other products: traces of Dapsone were found in the finished product.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0146-2018
- **Recalling firm:** Taro Pharmaceuticals U.S.A., Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-09-20
- **Report date:** 2017-11-01
- **Termination date:** 2020-09-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hawthorne, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0146-2018

## Citation

> AI Analytics. FDA recall D-0146-2018. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-0146-2018. Source: US FDA. Licensed CC0.

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