The undeclared diclofenac ingredient in “Artri Ajo King,” “Ortiga Mas Ajo Rey,” and “Artri King Reforzado con Ortiga y Omega 3” may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products. NSAIDs may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines.

2ĭiclofenac is a non-steroidal anti-inflammatory drug (NSAID). 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 contained the active pharmaceutical ingredient (API) diclofenac, which is not listed on the product labels. You can find the FD&C Act and FDA regulations through links on FDA’s home page at FDA purchased “Artri Ajo King,” “Artri King Reforzado con Ortiga y Omega 3,” and “Ortiga Mas Ajo Rey” products through your website, These products were introduced or delivered for introduction into interstate commerce by Amazon via your Fulfillment by Amazon service. As explained further below, introducing or delivering these products for introduction into interstate commerce is prohibited under sections 301(a), 301(d), and 505(a) of the FD&C Act, 21 U.S.C. Furthermore, these products are misbranded drugs under section 502(a) of the FD&C Act, 21 U.S.C. As discussed below, your firm is responsible for introducing, delivering, or causing the introduction or delivery into interstate commerce of these products, which are unapproved new drugs under section 505(a) of the FD&C Act, 21 U.S.C. This letter concerns your firm’s distribution of “Artri Ajo King Reforzado con Ortiga y Omega 3” (hereinafter “Artri Ajo King”), “Artri King Reforzado con Ortiga y Omega 3,” and “Ortiga Mas Ajo Rey” products that violate the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”).

Issuing Office: Center for Drug Evaluation and Research | CDER

Ortiga mas ajo rey review