What happened
Original notice title
Handelnine Global, LLC dba Navafresh MARCS-CMS 716013, November 17, 2025
From the archived source record
Based on our review, these products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). Furthermore, your “Rheumacare Capsules” product is a misbranded drug 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). The results of the FDA laboratory testing of two lots of “Rheumacare Capsules” demonstrate that this drug product is adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B), because the presence of lead in the amounts identified by FDA raises significant safety concerns and demonstrates that the product has not been manufactured and processed in a manner that conforms to CGMP requirements. Your Navafresh products are especially concerning from a public health perspective. As described below, the labeling of your unapproved “Dr. In addition, your unapproved “Ayuvision Herbal Eye Drop,” “Adel-17 Eye Care Drops,” and “Haslab Mamira Eye Drops” products are concerning because 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 Drug and Misbranding Violations Based on a review of your website, your Navafresh products are drugs under 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. Relieves Eye Dryness, Strain & Fatigue, Reduces Irritation & Itching and the Eye Drop Also Provides Eye Care from Harmful Environmental Pollutants.” Adel-17 Eye Care Drops On the webpage [see original source] From the product packaging: o “Supports the treatment for blurry, cloudy vision caused due to cataract or glaucoma as part of a complex treatment.” “Description . . .
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
- dd841b0bd601
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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