What happened
Original notice title
C & A Naturistics MARCS-CMS 693439, March 04, 2025
From the archived source record
As described below, these products are unapproved new drugs introduced or delivered for introduction into interstate commerce 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, your “AK Forte,” “TE DE MORONEL,” “Jengibre en Polvo,” “Té Uva Ursi,” and “RenaLimp” products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. 352, and introduced or delivered for introduction into interstate commerce 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 “AK Forte” product contains the undeclared active pharmaceutical ingredients acetaminophen and diclofenac. Acetaminophen overdose can cause liver damage (hepatoxicity), ranging in severity from abnormalities in liver function to acute liver failure, and even death. 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. Diclofenac may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products. We also note that your “Miel de Abeja Para Limpiar tus Ojos” and “Ojo Roja Para Limpiar tus Ojos” products are especially concerning from a public health perspective. Ophthalmic drug products, which are intended for administration into the eyes, in general pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses. Unapproved New Drugs Your “AK Forte,” “TE DE MORONEL,” “Jengibre en Polvo,” “Té Uva Ursi,” “RenaLimp,” “Miel de Abeja Para Limpiar tus Ojos,” and “Ojo Roja Para Limpiar tus Ojos” 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.
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
- 5a45b2fd652a
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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