Solace International Recalls Dermatend Ultra for Unapproved Labeling Claims
Solace International Inc. is recalling Dermatend Ultra skin tag remover because the product labeling contains unapproved claims and the product is not FDA approved.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves minor labeling errors with unapproved claims, which aligns with the Moderate severity criteria for labeling issues without reported injuries.
Plain-English summary
Solace International Inc. is recalling 1,249 containers and kits of Dermatend Ultra, a mole, wart, and skin tag remover. The product is distributed in 0.34 OZ (10g) containers and is labeled for external use only. The recall covers all lots of the product.
The recall was initiated because the product labeling bears unapproved claims. Dermatend Ultra is not FDA approved and has not been shown to be safe and effective for the uses suggested in the labeling. The product was distributed through Amazon US and Amazon UK.
Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions. The product is manufactured by Solace International Inc. in Reno, NV.
The recalled product
- 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
- Manufacturer
- Solace International Inc
- Category
- Drug — Topical OTC
- Hazard
- Affected units
- 1,249
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Solace International Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Solace International Inc
See all →- ModerateSolace International Recalls Dermatend Original for Unapproved Labeling Claims
FDA (Drugs) · 2014-09-24
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