Warning letterFDA · Nov 13, 2025
123Herbals MARCS-CMS 719198, November 13, 2025
Named company: 123Herbals
Based on our review, these products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). Furthermore, your “SILINTAN” product is a…
Lot information: not specified in this record.