November 2020 FDA Recall Drug by Fusion Health And Vitality Llc
D-0107-2021 - Marketed without an Approved NDA/ANDA

This Class II drug recall was voluntarily initiated by Fusion Health And Vitality Llc on November 18, 2020 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0107-2021

Reason for Recall
Marketed without an Approved NDA/ANDA: Product marketed with drug claims.
Initiated
11-18-2020
Reported
12-02-2020
Quantity
5000 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86834
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Fusion Health and Vitality LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the U.S.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-02-2023
Product Description About Product Description
Full technical description of the product.
Immune Boost with natural strawberry flavor, 8,000 IU, Supports a Healthy and Balanced Immune System, 60 mL bottle, Manufactured by: Fusion Health and Vitality, LLC. 1360 Union Hill Road, Suite 11B Alpharetta, GA 30004.

Batch or Lot Expiration Information

Lot# s: 200407, 200413, 200420, 200602, 200608.