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Recalls & Warnings
ConsumerLab.com is keeping you informed with current product recalls and warnings.
Posted September 3, 2019
Federal Court Shuts Down Two Supplement Companies Selling Weight, Joint Health and Other Supplements
The injunction bars the companies from receiving, labeling, holding or distributing dietary supplements drugs or devices until they take certain steps to ensure that all of these products comply with the law, including hiring qualified experts to ensure they are in compliance with cGMP and other requirements, and receiving written permission from the FDA to resume operations.
The companies were warned by the FDA in 2016 for multiple violations of Good Manufacturing Practices. However, the agency's new release about today's injunction noted, "Despite assurances that the violations noted in the warning letter would be corrected, follow-up inspections revealed that the defendants had failed to make the necessary corrections."
Basic Reset and Biogenyx sell a variety of products, including weight loss supplements such as Trimup and Slimup, "water enhancers" such as pH-FX and IONYTE that are promoted for energy and muscle and joint pain, as well as Primo Java, a coffee, mangosteen and reishi drink blend, and Energy Fx pendant necklaces that are promoted to "protect against electromagnetic frequencies."
See ConsumerLab's Reviews of Joint Health Supplements and Reishi Mushroom Supplements for more information about ingredients found in these products. Also see CL's answer to the question: Which supplements help to improve energy and decrease fatigue?
See related recalls and warnings:
Seller of Mineral, Joint Supplements and More Warned for Manufacturing Violations, Drug Claims
Department of Justice Files Complaint to Shut Down Supplement Company Federal Court Shuts Down Maker of Sexual Enhancement Products
Federal Court Shuts Down Seller of Supplement Promoted for Herpes
Supplement Manufacturer Shut Down for Manufacturing Violations
Company Ordered to Stop Making and Selling Supplements
To read the full news release, use the link below.
Report a Problem
If you have experienced an unexpected and adverse reaction to a dietary supplement, nutritional product, or generic drug, we would like to hear about it, as we may investigate the problem. Please select from one of these options:
Dietary Supplement or Nutritional Product Problem Report
If you believe that a dietary supplement (e.g., vitamin, mineral, or herbal supplement) or other nutritional product has caused an unexpected, adverse reaction, we would like to know about it. We are collecting and organizing this information and may publish it. We might test the product in the future. You may also want to report the problem to the U.S. FDA through their Safety Reporting Portal at https://www.safetyreporting.hhs.gov.
Please complete the form below as accurately as possible. You may need to check the label on the product.
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Generic Drug Problem Report
If you believe that a generic drug has not acted like the original drug, we would like to know about it. We are collecting and organizing this information and may publish it. We might test the product in the future. You may also want to report the problem to the U.S. FDA through their MedWatch program at the FDA MedWatch website.
Please complete the form below as accurately as possible. You may need to check the label on the drug.
Thank you for submitting your report.
