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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69135

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 28, 2014
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Solace International Inc

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 2

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

D-1585-2014
Recall number
D-1585-2014
Initiated
August 28, 2014
Classification
Class II
Status
Terminated
Recalling firm
Solace International Inc
Quantity
1606 containers

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

All lots

Distribution pattern

Amazon US and Amazon UK

drug · product 2 of 2

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

D-1586-2014
Recall number
D-1586-2014
Initiated
August 28, 2014
Classification
Class II
Status
Terminated
Recalling firm
Solace International Inc
Quantity
1249 containers and kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

All lots

Distribution pattern

Amazon US and Amazon UK

Field note

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