Drug & medication recalls Moderate risk

Fusion Health and Vitality LLC recalls Immune Boost with natural strawberry flavor, 8,000 IU, Supports a Healthy and Balanced Immune System, 60 mL bottle, Man…

Recall date
November 18, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0107-2021
FDA classification
Class II
Brand / firm
Fusion Health and Vitality LLC
Sold / distributed
Nationwide in the U.S.

Why it was recalled

Marketed without an Approved NDA/ANDA: Product marketed with drug claims.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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