D-1586-2014 Class II Terminated
FDA drug recall D-1586-2014 was initiated by Solace International Inc on August 28, 2014 and is designated Class II. 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. The recall status is terminated (terminated November 17, 2015). Affected quantity: 1249 containers and kits.
Recall Details
- Product Type
- Drugs
- Report Date
- September 24, 2014
- Initiation Date
- August 28, 2014
- Termination Date
- November 17, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1249 containers and kits
Product Description
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
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 Pattern
Amazon US and Amazon UK
Code Information
All lots