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Dermatend Original, mole, wart and skin tag remover, For external use only, Ingredient: Distilled...

FDA Recall #D-1585-2014 — Class II — August 28, 2014

Recall #D-1585-2014 Date: August 28, 2014 Classification: Class II Status: Terminated

Product Description

Dermatend Original, mole, wart and skin tag remover, For external use only, Ingredient: Distilled Water, Sanguinaria Canadensis, Vegetable Glycerin, Butter of Zinc, Germall Plus, 0.17 OZ (5g) 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.

Recalling Firm

Solace International Inc — Reno, NV

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

1606 containers

Distribution

Amazon US and Amazon UK

Code Information

All lots

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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