What happened
Original notice title
Latin Foods Market MARCS-CMS 631753, October 28, 2022
From the archived source record
The United States Food and Drug Administration (FDA) has obtained a sample and labeling of the product, “Artri King Reforzado con Ortiga y Omega 3.” As described below, this product is an unapproved new drug sold in violation of sections 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). Furthermore, this product is a misbranded drug under section 502(a) of the FD&C Act, 21 U.S.C. 352(a). FDA confirmed through laboratory analysis that a sample of your “Artri King Reforzado con Ortiga y Omega 3” contains the undeclared active pharmaceutical ingredients diclofenac and dexamethasone, which are not listed on the product label. 1 Dexamethasone is a corticosteroid commonly used to treat inflammatory conditions. In addition, the undeclared dexamethasone in “Artri King Reforzado con Ortiga y Omega 3” may cause serious side effects when combined with other medications. 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. The undeclared diclofenac ingredient in “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. Unapproved New Drug “Artri King Reforzado con Ortiga y Omega 3” is a drug as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1) because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body. In addition, “Artri King Reforzado con Ortiga y Omega 3” is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a).
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- 74955e14c624
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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