ISSUE: Solace International, Inc. is voluntarily recalling all lots of Dermatend Original and Dermatend Ultra, in all sizes and dosage forms, to the distributor/wholesaler level. A mole should be removed under the supervision of a dermatologist. 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.
BACKGROUND: Currently, the Dermatend Original and Dermatend Ultra products are used to remove moles, warts and skin tags. Dermatend Original and Dermatend Ultra are packaged in a flexible plastic tubes labeled with the product name in blue letters. All units and lots are affected by the recall.
RECOMMENDATION: 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. Consumers who purchased Dermatend Original and Dermatend Ultra to remove moles and warts should immediately discontinue use and consult their physician. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[08/28/2014 - Press Release - Solace International]