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Walmart distributed "Artri King Reforzado con Ortiga y Omega 3," an unapproved new drug that violated the Federal Food, Drug, and Cosmetic Act by being introduced into interstate commerce without FDA approval and with false labeling. FDA laboratory testing confirmed the product contained the undeclared active pharmaceutical ingredient diclofenac, a non-steroidal anti-inflammatory drug (NSAID) not listed on the label, which carries serious risks including cardiovascular events, gastrointestinal bleeding, and dangerous interactions with other medications. The product was purchased by FDA through Walmart.com and fulfilled by Walmart Fulfillment Services, establishing Walmart's direct responsibility for the violation.