![]() 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”). Consumers should exercise caution before purchasing any product in the above categories.Issuing Office: Center for Drug Evaluation and Research | CDER These products are typically promoted to unsuspecting customers for sexual enhancement, weight loss, and body building, or for other medical uses and are often represented as being “all natural.” FDA is unable to identify and test all such products that may have potentially harmful hidden ingredients. Note: The purpose of this notification is to inform the public of a growing trend of dietary supplements or conventional foods containing hidden drugs and chemicals. Download form or call 1-80 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-80.Complete and submit the report Online:.Health care professionals and patients are encouraged to report adverse events or side effects related to Ortiga to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: ![]() Consumers should consult a health care professional as soon as possible if they have experienced any negative side effects, such as unusually dark stools or urine, stomach pain, increased bruising, or other signs of bleeding. This hidden drug ingredient may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products.Ĭonsumers should stop using this product immediately and dispose of it. Diclofenac is a non-steroidal anti-inflammatory drug (commonly referred to as NSAIDs). The product is manufactured in Mexico and labeled primarily in Spanish.įDA laboratory analysis confirmed that Ortiga contains the prescription drug ingredient, diclofenac. The Food and Drug Administration (FDA) is advising consumers not to purchase or use Ortiga, an unapproved product promoted for a variety of health conditions and sold on multiple websites, including and in some retail stores.
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