September 9, 2014 — The FDA is recalling a popular at-home product for removing warts, moles, and skin tags because it is not approved. People with these skin conditions need to be evaluated by a doctor because they might be melanoma (skin cancer).
The recall was issued by the manufacturer, Solace International Inc., for Dermatend Original and Dermatend Ultra.
The recall affects all lots, sizes, and doses. The products were distributed nationwide at the distributor and wholesale level. Each product is packaged in a flexible plastic tube with the name “Dermatend” in blue letters. Solace International is based in Reno, Nevada and products were sold for about $30 each.
The FDA warns:
“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.”
Solace International recommends that consumers who purchased Dermatend should immediately stop using it and contact a doctor.
The risk is that a patient with highly-aggressive melanoma (skin cancer) might use Dermatend instead of seeking medical attention. Delayed diagnosis of skin cancer increases the risk that it will spread to other areas of the body (metastasize) and become impossible to cure.
Melanoma is the deadliest type of skin cancer. Other types of skin cancer include basal cell carcinoma and squamous cell carcinoma. These cancers cannot be self-diagnosed and only a skin biopsy can conclusively diagnose cancer.
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