Dermatend Original and Ultra are not FDA approved.
Solace International, Inc., Reno, NV, is voluntarily recalling all lots of Dermatend Original and Dermatend Ultra, in all sizes and dosage form, to the distributor/wholesaler level. 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.
Currently, the Dermatend Original and Dermatend Ultra products are used to remove moles, warts and skin tags. All units and lots are affected by the recall.
Solace International, Inc. is notifying its distributors/wholesalers by certified letter and is arranging for the return of all recalled products.
Distributors/wholesalers that have Dermatend Original and Dermatend Ultra product, which is being recalled, should return all units and cases to Solace International, Inc.