Medicine recalls
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| The United States: FDA underscores that consumers should not use drugs, dietary supplements and devices recalled from Basic Reset and Biogenyx following consent decree for federal violations |
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The US Food and Drug Administration (FDA) is alerting consumers of a recall of 25 drug, dietary supplement and medical device product lines distributed by Basic Reset and Biogenyx of Hendersonville, Tennessee. In September, a federal court entered a consent decree of permanent injunction between the United States and the two companies and their owner, Fred R. Kaufman III. Under the consent decree, Basic Reset and Biogenyx must recall and stop distributing products until the companies comply with the Federal Food, Drug, and Cosmetic Act and other requirements listed in the consent decree.
Basic Reset and Biogenyx products that have been recalled include drugs such as Earth Wash and Ionyte. For details of the affected products, please refer to the website in FDA.
Basic Reset and Biogenyx have not received the FDA’s approval for the sale of their drugs, despite the companies’ claims that these products can be used to diagnose, cure, mitigate, treat or prevent conditions such as inflammation, chronic diarrhea, bacterial infections, head lice, allergies and pain. Consumer use of an unapproved product that claims to treat diseases may cause them to delay seeking appropriate medical care. Additionally, unapproved products have not been reviewed by the FDA for quality, safety or effectiveness. Basic Reset and Biogenyx also unlawfully distributed dietary supplements that are adulterated and misbranded. FDA has not received any adverse event reports related to these products.
Please refer to the following website in FDA for details:
http://www.fda.gov/news-events/press-announcements/fda-underscores-consumers-should-not-use-drugs-dietary-supplements-and-devices-recalled-basic-reset
In Hong Kong, the above products are not registered pharmaceutical products. Related news was previously issued by FDA, and was posted on the Drug Office website on 4 Sep 2019.
Ends/Wednesday, Dec 11, 2019
Issued at HKT 16:00
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