Immune Boost with natural strawberry flavor, 8,000 IU, Supports a Healthy and Balanced Immune Sys...
FDA Recall #D-0107-2021 — Class II — November 18, 2020
Product Description
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.
Reason for Recall
Marketed without an Approved NDA/ANDA: Product marketed with drug claims.
Recalling Firm
Fusion Health and Vitality LLC — Alpharetta, GA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
5000 bottles
Distribution
Nationwide in the U.S.
Code Information
Lot #s: 200407, 200413, 200420, 200602, 200608.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated