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Supplement facing recall over unapproved, ‘possibly unsafe’ additive

Two dietary supplements are facing a recall, according to a notice posted to the U.S. Food and Drug Administration’s website this week. 

In a notice posted to the FDA’s website on Monday, Fusion Health and Vitality LLC said all of its 2020 lots of Core Essential Nutrients and of Immune Boost Sublingual Vitamin D3 are subject to the recall, each for different reasons.

This product has been found to contain an unapproved food additive, hordenine HCl, per the FDA notice.

This product has been found to contain an unapproved food additive, hordenine HCl, per the FDA notice.
(FDA)

The first, the company’s Core Essential Nutrients supplement, was found to contain an unapproved food additive known as hordenine HCl.

Hordenine HCl, according to the recall notice, “is possibly unsafe when taken by mouth. Hordenine HCl might have similar stimulant effects and side effects such as rapid heart rate and high blood pressure.” 

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The Core Essential Nutrients supplement was first shipped on Jan. 2 of this year, per the notice. 

"Immune Boost Labeling was found to contain statements that caused it to become and unapproved new drug under FDA labeling laws," per the notice.

“Immune Boost Labeling was found to contain statements that caused it to become and unapproved new drug under FDA labeling laws,” per the notice.
(FDA)

The recall also affects the company’s Immune Boost Sublingual Vitamin D3 over a labeling issue. 

“Immune Boost Labeling was found to contain statements that caused it to become an unapproved new drug under FDA labeling law,” the notice reads. 

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No adverse reactions related to either product have been reported to date, however. 

“Fusion Health and Vitality is notifying its customers by email and is arranging for return of all recalled products,” the company said. “Consumers that have product which is being recalled should stop using it and return it to Fusion Health and Vitality for destruction.”

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Consumers with further questions can contact Fusion Health and Vitality at 1-888-964-5327. 

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