# FDA recall D-1152-2014

> **Fougera Pharmaceuticals  Inc.** · Class III · drug recall initiated 2014-01-29.

## Product

Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E. Fougera & Co., A division of Fougera Pharmaceuticals Inc., Melville, New York  11747, NDC 0168-0004-80, UPC 3 0168-0004-80 8.

## Reason for recall

Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%.

## Distribution

Nationwide.

## Key facts

- **Recall number:** D-1152-2014
- **Recalling firm:** Fougera Pharmaceuticals  Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-01-29
- **Report date:** 2014-03-19
- **Termination date:** 2015-12-08

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1152-2014

## Citation

> AI Analytics. FDA recall D-1152-2014. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1152-2014. Source: US FDA. Licensed CC0.

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