# FDA recall D-1169-2014

> **Fabscout Entertainment, Inc** · Class I · drug recall initiated 2013-06-27.

## Product

Clalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language)

## Reason for recall

Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that the products was found to contain sildenafil, an undeclared active pharmaceutical ingredient.

## Distribution

Nationwide and France

## Key facts

- **Recall number:** D-1169-2014
- **Recalling firm:** Fabscout Entertainment, Inc
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-06-27
- **Report date:** 2014-03-26
- **Termination date:** 2019-10-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ft Lauderdale, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1169-2014

## Citation

> AI Analytics. FDA recall D-1169-2014. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/D-1169-2014. Source: US FDA. Licensed CC0.

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