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Solace issues voluntary recall of Dermatend mole, wart remover
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Solace International has voluntarily recalled all lots of Dermatend Original and Dermatend Ultra, in all sizes and dosages, to the distributor/wholesaler level, according to a press release from the U.S. Food and Drug Administration.
Dermatend is not FDA-approved. The FDA warns that using Dermatend products instead of seeking medical attention could result in delayed diagnosis of certain conditions, including cancer.
Dermatend Original and Dermatend Ultra are used to remove moles, warts and skin tags. Both products are packaged in a flexible plastic tube with the product name in blue letters, according to the release.
Solace International is notifying its distributors/wholesalers by certified letter and is arranging for the return of all recalled products.
Consumers who purchased Dermatend Original and Dermatend Ultra should discontinue use immediately and consult their physician, according to the release.
The FDA urges health care professionals and patients to report adverse events or side effects related to the use of these products to FDA’s MedWatch Safety Information and Adverse Event Reporting Program online, via downloaded form or by calling 1-800-332-1088.