September 9, 2014 — Solace International, Inc. has issued a recall for all units and lots of Dermatend at-home mole, wart, and skin-tag removal cream for safety reasons.
The recall affects Dermatend Original and Dermatend Ultra products. The manufacturer never obtained approval to sell the products and moles should only be removed under the supervision of a healthcare professional.
According to the FDA:
“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.”
Moles and warts could potentially be melanoma or non-melanoma skin cancer (such as basal cell carcinoma or squamous cell carcinoma). It is essential to diagnose melanoma early because it is the deadliest form of skin cancer. Melanoma can rapidly spread beyond the skin and metastasize in other areas of the body.
The recall affects products that were sold in all sizes and doses at the distributor and wholesale level. They were packaged in flexible plastic tubes with the product name in blue letters. Dermatend products were manufactured in Reno, Nevada and sold nationwide for about $30.
Solace International has arranged for distributors and wholesalers to return the products. Customers who purchased the products should immediately stop using them and contact a physician.
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