Recall of Mole Product Causes Safety Concerns

Solace International, Inc. is recalling all lots of Dermatend Original and Dermatend Ultra, in all sizes and dosage forms. Dermatend Original and Dermatend Ultra products were promoted to remove moles, warts and skin tags. Consumers who purchased Dermatend Original and Dermatend Ultra to remove moles and warts should immediately discontinue use and consult their physician. Dermatend Original and Dermatend Ultra are packaged in flexible plastic tubes labeled with the product name in blue letters. All units and lots are affected by the recall.

Risk:A mole should be removed under the supervision of a dermatologist. Dermatend is not FDA approved, and 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.

Recommendations

• Consumers should immediately stop using these products and consult their physician.
• Consumers can call Solace International, Inc. at 1-775-323-1413 Mon. – Fri. 8 a.m. until 5 p.m. PT.