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Recalls & Warnings
ConsumerLab.com is keeping you informed with current product recalls and warnings.
Posted April 11, 2013
Glutathione Supplement Maker Warned For Manufacturing Violations and Drug Claims
These violations include failure to establish specifications for each component used in the manufacture of a dietary supplement, failure to prepare a written master manufacturing record for each unique dietary supplement formulation, and failure to establish and follow written procedures for the responsibilities of the quality control operations.
In addition, statements made on the company's website about Ultrathione 500 Glutathione, Ultrathione 1000 Sports Pack, Ultrathione Performance, Ultrathione Extreme Performance, Ultrathione Health Pack, Ophthalmic Nutrients 1500, Ultimate Travel Smart & Strong, Guardian, and Ultrathione Extreme Performance were determined to be drug claims.
These products were promoted for a variety of uses with statements such as "people who use APC's Glutathione products…have a significant reduction in Seasonal Respiratory Infections," and "GSH corrects pathologic processes that are found…in…diseases such as Pulmonary Emphysema, Cystic Fibrosis, Pulmonary Hypertension, and Diabetic Vascular Complications."
These products were also found to be misbranded due to improper labeling. The nutrition information, for example, was not enclosed within a Supplement Facts Panel box, as required by federal regulations.
See ConsumerLab.com's answer to the question, Do glutathione supplements work to prevent aging or for other conditions?, and see Reviews of Alpha Lipoic Acid Supplements and Vitamin C Supplements (both of which are thought to play a role in glutathione levels) for tests of related products.
For more information about this warning, 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.
Thank you for submitting your report.
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.
