Medicine recalls
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| The United States: Fusion Health and Vitality issues voluntary nationwide recall of CORE Essential Nutrients and Immune Boost Sublingual Vitamin D3 due to the unapproved use of a food additive and unapproved marketing statements |
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The US Food and Drug Administration (FDA) announces that Fusion Health and Vitality LLC is voluntarily recalling all 2020 lots of CORE Essential Nutrients and Immune Boost Sublingual Vitamin D3 (8000 IU). CORE has been found to contain an unapproved food additive, hordenine HCl, rendering it adulterated. Immune Boost labeling was found to contain statements that caused it to become and unapproved new drug under FDA labeling laws. Hordenine HCl 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.
Fusion Health and Vitality LLC has not received any reports of adverse events related to this recall.
CORE Essential Nutrients is found in a dark colored jar, in powdered format. This product was formulated to mix into a liquid before consumption. Immune Boost Sublingual Vitamin D3 is packaged in a 2 ounce bottle with a sublingual application dropper.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fusion-health-and-vitality-issues-voluntary-nationwide-recall-core-essential-nutrients-and-immune
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Tuesday, Nov 24, 2020
Issued at HKT 15:00
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