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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

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Dietary Supplements
Drugs

Reason for Announcement:

Recall Reason Description

Unapproved new drug

Company Name:
Fusion Health and Vitality LLC
Brand Name:

Brand Name(s)

CORE, Immune Boost

Product Description:

Product Description

CORE essential nutrients and Immune Boost Sublingual Vitamin D3


Company Announcement

Fusion Health and Vitality LLCis voluntarily recalling all 2020 Lots of CORE essential nutrients and Immune Boost Sublingual Vitamin D3. 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.  Please review the attached photos for identification.

We began shipping Core Essential Nutrients on 1/2/2020 and we began shipping Immune Boost Sublingual Vitamin D3 on 4/15/2020.

Both products are packaged with labels which prominently display the product name.  CORE essential nutrients are found in a dark colored jar, in powdered format.  This product was formulated to mix into a liquid before consumption.

The Immune Boost sublingual was packaged in a 2 ounce bottle that came with a sublingual application dropper.

Fusion Health and Vitality is notifying its customers by email and is arranging for return of all recalled products.

Consumers that have product which is being recalled should stop using it and return it to Fusion Health and Vitality for destruction.

Consumers with questions regarding this recall or how to return recalled product can contact Fusion Health and Vitality by calling 1-888-964-5327, 9am to 5pm, Monday Thru Friday, EST.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.


Company Contact Information

Consumers:
Fusion Health and Vitality
Media:
Spencer Jargon


Product Photos

Go to Source
Author: FDA

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