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”). Methocarbamol may cause dizziness and low blood pressure, it said.Issuing Office: Center for Drug Evaluation and Research | CDER The Artri King products are made by supplements maker NaturaMex.ĭexamethasone could cause serious adverse events including infections and elevated sugar levels while diclofenac sodium could lead to heart attack and stroke or gastrointestinal damage, the FDA warned on Wednesday. The agency said it has received reports of adverse events including of liver toxicity and death, associated with the use of Artri King products since the warning. The FDA in January had first issued a warning about Artri Ajo King, asking consumers not to purchase the product sold for joint pain and arthritis on various websites, including. The FDA said it found the hidden drug ingredients in Artri Ajo King, Artri King, Ortiga Mas Ajo Rey and Ortiga Mas Ajo Rey Extra Forte products. The products are marketed to treat arthritis, muscle pain and other conditions and are sold online and in some retail stores, the agency said. The agency said its laboratory analyses revealed some of the products contain dexamethasone, a corticosteroid, anti-inflammatory drug diclofenac sodium and methocarbamol, which is a muscle relaxant. Food and Drug Administration (FDA) on Wednesday asked people to not buy or use certain dietary supplement products sold with variations of the names 'Artri' or 'Ortiga' as they may contain some potentially harmful ingredients not mentioned on their labels.
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