The Recall Desk

FDA (Drugs) recall action 69135

Solace International Inc recalled 2 products on 2014-09-24

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2014-09-24
Critical
0
Units
2,855

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Drugs)··2014-09-24

    Solace International Recalls Dermatend Original for Unapproved Labeling Claims

    Solace International is recalling Dermatend Original mole and wart remover because the label contains unapproved claims. The product is not FDA approved.

    Product
    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
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2014-09-24

    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.

    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
    Category
    Distribution
    0 states