Lydia Co. Ltd. – FDA Warning Letter, Jul 4, 2023
The FDA issued a Warning Letter to Ho Dong Yang on June 26, 2023, regarding discrepancies in drug listing information for eight products: Hot Pap Cataplasma, Amuldy Sports Gel, Zenol Cool, Antiphlamine, Mentholatum, New Hanbang Col Cap, Nocold-S, and Albothyl.
The FDA's review of the firm's electronic Drug Registration and Listing System (eDRLS) submissions revealed contradictory information between the product labeling and the electronic listing files. This follows a March 17, 2023, deficiency letter and a May 1, 2023, data removal notification, which resulted in the products' data being removed from FDA’s Online NDC Directory.
Violations include: * **Hot Pap Cataplasma (NDC 72988-0007):** Mismatched active ingredients (labeling includes methyl salicylate and vanillyl nonylamide; listing only methyl salicylate) and incomplete package quantity information (labeling indicates 5 sheets; listing only 1 sheet). This violates 21 CFR 207.49(a)(4) and 21 CFR 207.49(a)(2). * **Amuldy Sports Gel (NDC 72988-0023):** Mismatched active ingredients (labeling includes ment
ID · f0290d5e-2540-4a67-adf8-0ae036ab8650
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.