# FDA recall D-0676-2017

> **Taro Pharmaceuticals U.S.A., Inc.** · Class II · drug recall initiated 2017-03-28.

## Product

Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units and 1 mg triamcinolone acetonide, distributed in a) 15 grams (NDC 51672-1263-1), b) 30 grams (NDC 51672-1263-2)  and c) 60 grams (NDC 51672-1263-3) tubes, Rx only, TARO label;  Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1 -- Dist. by: Taro Pharmaceuticals U.S.A. Inc., Hawthorne, NY 10532

## Reason for recall

Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-0676-2017
- **Recalling firm:** Taro Pharmaceuticals U.S.A., Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-03-28
- **Report date:** 2017-04-26
- **Termination date:** 2019-06-17

- **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-0676-2017

## Citation

> AI Analytics. FDA recall D-0676-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0676-2017. Source: US FDA. Licensed CC0.

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