September 2, 2014
Solace International, Inc. Recalls Dermatend Original and Dermatend Ultra
The Missouri Department of Health and Senior Services received information regarding the recall of Dermatend Original and Dermatend Ultra, in all sizes and dosage form, to the distributor/wholesaler level. 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.
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.
The full recall can be found at: www.fda.gov/Safety/Recalls/ucm412302.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery.