Federal safety officials have forced a recall for Dermatend mole remover products, indicating that they have never been shown to be safe or effective, and promotion of the at-home treatments raise safety concerns, since they may delay diagnosis of serious conditions, such as cancer.
A Dermatend Original and Ultra recall was announced by the FDA on August 28, indicating that the manufacturer never obtained the agency’s approval to sell the products promoted over-the-counter for use to remove moles, warts, and skin tags.
In a statement issued by the FDA, the health regulators indicated that moles should only be removed under the supervision of a dermatologist. The agency also warns that the use of Dermatend or other over-the-counter products may cause delays in seeking medical attention for suspicious skin developments, which may be early symptoms of serious medical conditions such as cancer.
The products being recalled are Dermatend Original and Dermatend Ultra products sold in all sizes and dosage forms at the distributor and wholesale levels. The products were packaged and sold in flexible plastic tubes labeled with instructions on how to apply the treatments to remove warts, moles, and skin tags. The plastic tubes also have the product name printed across the front in blue letters.
Dermatend products were manufactured by Solace International, Inc. of Reno, Nevada, where they were sold nationwide at the wholesale and distributor level for around $30. Solace International is notifying its distributors by certified letter and arranging for the return of all recalled products.
The FDA warns that consumers who purchased Dermatend Original or Ultra to remove mole, warts, or skin tags should immediately discontinue using the products and consults their healthcare physician. Customers with questions regarding the recall should contact Solace International at 775-323-1413 or email them at firstname.lastname@example.org.