FDA recall D-1585-2014

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

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

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

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1585-2014