What happened
Original notice title
MYA International, Inc. MARCS-CMS 619877, February 24, 2022
From the archived source record
Based on the inspection and our subsequent review of product labeling collected during the inspection, FDA identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act). Unapproved New Drugs/Misbranded Drugs The Food and Drug Administration (FDA) reviewed your product labels for Hygly, Diapro-Z, Bioampixilina, Penalin, Colloidal Silver, Tea (Tea Cellular), Quiebra Piedras, Shark Cartilage, and Helper following this inspection. PRINCIPALES USOS: … elimina las obstrucciones, erradica los cálculos, reduce las inflamaciones, . . . desintoxica el hígado, … reduce el nivel de azúcar en la sangre, reduce la presión sanguínea y el colesterol.” Which translates in English to: “The antispasmodic activity of the stone crushing alkaloids showed slight muscle relaxation specific to the urinary tract and bile duct, for which the researchers attributed facilities an ease in the expulsion of bladder and kidney stones. A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). Accordingly, Hygly, Diapro-Z, Bioampixilina, Penalin, Colloidal Silver, Tea (Tea Cellular), Quiebra Piedras, Shark Cartilage, and Helper fail to bear adequate directions for their intended use and, therefore, the products misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)]. Dietary Supplement cGMP Violations: The inspection revealed serious violations of the FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111).
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
- 9571b98d0c55
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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