What happened
Original notice title
Evimeria El Aztecano, Inc. MARCS-CMS 624797, November 16, 2022
From the archived source record
Based on our subsequent review of the product labeling, we have concluded that this product is in violation of section 403 of the Federal Food, Drug and Cosmetic Act (the Act) and the regulations contained within Title 21, Code of Federal Regulations, Part 101 (21 CFR Part 101). Your “Yerbas Finas Leche de Alpiste con Guanabana y Omega-3” product is misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] because its labeling is false or misleading. Because your “Yerbas Finas Leche de Alpiste con Guanabana y Omega-3” dietary supplement does not contain levels of magnesium or potassium at least equal to 80 percent of the value declared on the label for each nutrient, as required by 21 CFR 101.9(g)(4)(ii), the product’s label is false or misleading. 2. Your “Yerbas Finas Leche de Alpiste con Guanabana y Omega-3” is misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product label bears nutrient content claims but does not meet the requirements to bear such claims. Characterizing the level of a nutrient in the food labeling of a product without complying with the specific requirements pertaining to nutrient content claims for that nutrient misbrands the product under section 403(r)(1)(A) of the Act. Your “Yerbas Finas Leche de Alpiste con Guanabana y Omega-3” product is misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the presentation of the nutritional information on the labeling of your product does not comply with 21 CFR 101.36. Your “Yerbas Finas Leche de Alpiste con Guanabana y Omega-3” product is misbranded within the meaning of section 403(f) of the Act [21 U.S.C. § 343(f)] because the product label contains information in two languages but does not repeat all of the required information in both languages.
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
- 947adb80d457
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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