FDA WARNING_LETTER - Save Rite Medical - November 03, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Save Rite Medical on November 13, 2025, concerning the online sale of "Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan." Following a review of the company"s website, the FDA determined these products violate the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The primary violation is that these triclosan-containing soaps are marketed as unapproved new drugs and are also misbranded. The FDA has definitively stated that topical consumer and healthcare antiseptic products containing triclosan are not generally recognized as safe and effective. Consequently, marketing these products without FDA approval contravenes sections 505(a) and 301(d) of the FD&C Act, which prohibit the introduction of unapproved new drugs into interstate commerce. Furthermore, they are deemed misbranded under section 502(ee) for failing to comply with nonprescription drug marketing requirements.

Save Rite Medical is required to submit a written response to the FDA within 15 working days. This response must detail the specific corrective actions taken, outline measures to prevent future violations, and include supporting documentation. The FDA cautioned that a failure to adequately address these issues could lead to further legal action, including product seizure and injunction.