Walmart Inc.
FDA issued a warning letter to Walmart Inc. (CEO Doug McMillon) regarding its distribution of 'Artri King Reforzado con Ortiga y Omega 3,' a product sold via Walmart.com and fulfilled through Walmart Fulfillment Services. Laboratory analysis confirmed the product contained undeclared diclofenac, an NSAID not listed on the label, rendering it an unapproved new drug and a misbranded drug under the FD&C Act. The product's labeling made multiple disease-treatment claims (arthritis, joint deterioration, cartilage restoration) that established drug intent without FDA approval. FDA demanded a written response within 15 working days and warned that failure to comply could result in seizure and/or injunction.
Flagged claims (9)
Combate la artritis.
Altamente eficaz en la reconstruccion del cartílago.
Beneficia a personas que padecen de procesos degenerativos como artritis y osteoartritis.
Altamente eficaz en la reconstruccion del cartílago.
Mejora la movilidad y normal funcionamiento de las articulaciones.
Antiinflamatorio y analgésico.
Detiene el avance de deterioro en articulaciones.
The labeling for "Artri King Reforzado con Ortiga y Omega 3" does not declare that the products contain the drug ingredient diclofenac.
Eficaz en problemas de articulaciones de lesiones deportivas.
Required actions (2)
Please submit a written response to this letter within fifteen working days from the date of receipt, explaining the specific steps you have taken to address any violations.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and/or injunction.
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