FDA warning letter · Drugs

Amazon.com, Inc.

Issued · Posted by FDA

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

FDA confirmed through laboratory analyses that the “Artri Ajo King,” “Ortiga Mas Ajo Rey,” and “Artri King Reforzado con Ortiga y Omega 3” purchased on Amazon.com contained the active pharmaceutical ingredient (API) diclofenac, which is not listed on the product labels.

Passage 2

The respective labeling for “Artri Ajo King,” “Artri King Reforzado con Ortiga y Omega 3,” and “Ortiga Mas Ajo Rey” does not declare that the products contain the drug ingredient diclofenac.