FDA WARNING_LETTER - Lydia Co. Ltd. - July 04, 2023

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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

Company: Lydia Co. Ltd.
Inspection Date: July 4, 2023
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Tina Smith (Director)

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ID · f0290d5e-2540-4a67-adf8-0ae036ab8650

Violation Codes10

21 CFR 207.49(a)(4)21 CFR 207.49(a)(2)21 CFR 207.49(a)(6)21 U.S.C. 360(j)21 U.S.C. 331(p)21 U.S.C. 352(o)FD&C Act 510(j)FD&C Act 301(p)FD&C Act 502(o)FD&C Act 301(a)

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