May 31, 2016
The U.S. Food and Drug Administration (FDA) announced the recall of capsaicin, 0.0375%, menthol, USP (Renovo Patch), three-count patches per carton.
What prompted the Class II recall? The FDA noted that the product was being marketed without an approved NDA/ANDA. Additionally, three lots were found to be subpotent.
TMIG Inc of Marietta, Georgia, is voluntarily recalling all lots. The total number impacted was not reported.
The products were distributed nationwide.
1. U.S. Food and Drug Administration. Enforcement Report – Week of May 25, 2016. www.fda.gov. Accessed May 25, 2016.