Recalls and Warnings
(Date Posted: 2/18/2020)
|Seller of CoQ10, Resveratrol and More Warned for Manufacturing Violations
On February 5, 2020, the FDA issued a warning letter to R-Garden LLC, which found the company's Vitamin O, Gamma-Zyme, L. Salivarius, Vitamin B-12, Colloidal Silver, Protease Plus, Sun Energy, Cordyceps, Cordyceps Plus, Amylase Formula, Lipase Formula, Maximizer, and Quadra-Zyme Plus to be adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.
These violations include failure to establish the required specifications for quality control of the dietary supplement and failure to establish specifications for dietary supplement labels, as required by federal regulations.
In addition, certain statements made about the products Vitamin O, Gamma-Zyme, Colloidal Silver, Protease Plus, Sun Energy, Maximizer, Multi-Vitamin Plus, Resveratrol Complex. and CoQ-10 Formula on the company's website and product catalog were found to be drug claims products. For example, Protease Plus was promoted with statements such as "Protease Plus also can be of tremendous help when dealing with the toxins and bacteria that are circulating in the blood stream."
R-Garden LLC was warned by the FDA in 2005 for making unsubstantiated drug claims about their Vitamin O product.
See ConsumerLab.com's Reviews of CoQ10 and Ubiquinol Supplements, Multivitamin Supplements, Resveratrol Supplements, and B Vitamin Supplements for tests of related products.
Also see our answer to the question Is ingesting colloidal silver helpful for any condition and is it safe to use?
See related recalls and warnings:
Seller of Tea, Colloidal Silver, Homeopathic Products Warned for Manufacturing Violations
Seller of B Vitamins, Multis, Glucosamine & More Warned for Manufacturing Violations
Seller of CoQ10, SAM-e, Vitamin D, and More Warned for Manufacturing Violations, Drug Claims
Seller of Sexual Enhancement, Cholesterol, Resveratrol Supplements and More Warned For Drug Claims
For more information, use the link below.
Warning Letter: R-Garden LLC
For other Recalls and Warnings click HERE.
For information about reporting serious reactions and problems with medical products to the U.S. Food and Drug Administration through its MedWatch reporting program, please go to http://www.fda.gov/medwatch/how.htm.