# FDA recall D-1044-2014

> **Fougera Pharmaceuticals  Inc.** · Class III · drug recall initiated 2013-11-18.

## Product

KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0099-30, UPC 3 0168-0099-30 9.

## Reason for recall

Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-1044-2014
- **Recalling firm:** Fougera Pharmaceuticals  Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-11-18
- **Report date:** 2014-02-05
- **Termination date:** 2016-05-09

- **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-1044-2014

## Citation

> AI Analytics. FDA recall D-1044-2014. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1044-2014. Source: US FDA. Licensed CC0.

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