What happened
Original notice title
Botanical Be MARCS-CMS 671066, December 21, 2023
From the archived source record
As described below, these products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, the products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. 352 and sold in violation of section 301(a) of the FD&C Act, 21 U.S.C. 331(a). FDA confirmed through laboratory analysis that a sample of your “Kuka Flex Forte,” “Reumo Flex,” and “Artri King Reforzado con Ortiga y Omega 3” contains undeclared diclofenac. 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. 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. Unapproved New Drugs Your “Kuka Flex Forte,” “Reumo Flex,” and “Artri King Reforzado con Ortiga y Omega 3” products are drugs as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1) because they are 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. Misbranded Drug Your “Kuka Flex Forte,” “Reumo Flex,” and “Artri King Reforzado con Ortiga y Omega 3” products are misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a). Under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the FD&C Act, 21 U.S.C. 321(n), provides that, in determining whether an article’s labeling or advertising “is misleading there shall be taken into account…not only representations made or suggested…but also the extent to which the labeling or advertising fails to reveal facts material in light of such representations.” The labeling for “Kuka Flex Forte,” “Reumo Flex”, and “Artri King Reforzado con Ortiga y Omega 3” does not declare that the products contain the drug ingredient diclofenac.
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
- c3d94a43d190
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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