Washington, DC: Solace International, Inc. is recalling all lots of Dermatend Original and Dermatend Ultra, in all sizes and dosage forms, to the distributor/wholesaler level.
Currently, the Dermatend Original and Dermatend Ultra products are used to remove moles, warts and skin tags. A mole should be removed under the supervision of a dermatologist. Dermatend is not FDA approved, thus has not been shown to be safe and effective for the uses suggested in the labeling. Using these Dermatend products instead of seeking medical attention could result in delayed diagnosis of conditions such as cancer, the FDA warns.
Dermatend Original and Dermatend Ultra are packaged in a flexible plastic tubes labeled with the product name in blue letters. All units and lots are affected by the recall.