# FDA recall D-0245-2015

> **Fougera Pharmaceuticals  Inc.** · Class II · drug recall initiated 2014-08-28.

## Product

FLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalmic Use, a) NET WT 15 gram tubes and b) NET WT 60 grams tubes, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0135-15 (15 g) and NDC 0168-0135-60 (60 g)

## Reason for recall

Failed Stability Specifications: The lots of Fluocinonide Gel USP, 0.05% recalled, may not meet the requirements for residual solvents as outlined in USP <467>.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-0245-2015
- **Recalling firm:** Fougera Pharmaceuticals  Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-08-28
- **Report date:** 2014-11-19
- **Termination date:** 2016-06-21

- **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-0245-2015

## Citation

> AI Analytics. FDA recall D-0245-2015. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0245-2015. Source: US FDA. Licensed CC0.

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