# FDA recall D-241-2013

> **Fougera Pharmaceuticals  Inc.** · Class III · drug recall initiated 2012-07-18.

## Product

Fougera Ketoconazole Cream 2%, 15g tube, Rx only, Labeled with E. Fougera & Co., a division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0099-15

## Reason for recall

Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary drug recall by Fougera due to an Out Of Specification result for an unknown degradant product

## Distribution

Nationwide

## Key facts

- **Recall number:** D-241-2013
- **Recalling firm:** Fougera Pharmaceuticals  Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-07-18
- **Report date:** 2013-04-10
- **Termination date:** 2015-12-10

- **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-241-2013

## Citation

> AI Analytics. FDA recall D-241-2013. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-241-2013. Source: US FDA. Licensed CC0.

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