# FDA recall D-1586-2014

> **Solace International Inc** · Class II · drug recall initiated 2014-08-28.

## Product

Dermatend Ultra, mole, wart and skin tag remover, For external use only, Ingredient: Distilled Water, Sanguinaria Canadensis, Vegetable Glycerin, Butter of Zinc, Germall Plus, 0.34 OZ (10g) container, Solace International, Inc., Reno, NV 89509, USA

## Reason for recall

Labeling: Labeling Bears Unapproved Claims; Dermatend is not FDA approved and therefore has not been shown to be safe and effective for the uses suggested in the labeling.

## Distribution

Amazon US and Amazon UK

## Key facts

- **Recall number:** D-1586-2014
- **Recalling firm:** Solace International Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-08-28
- **Report date:** 2014-09-24
- **Termination date:** 2015-11-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Reno, NV, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1586-2014

## Citation

> AI Analytics. FDA recall D-1586-2014. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-1586-2014. Source: US FDA. Licensed CC0.

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