FDA recall D-0107-2021

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.

Reason for recall

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

Distribution

Nationwide in the U.S.

Key facts

Status

Terminated

Initiation date

2020-11-18

Report date

2020-12-02

Termination date

2023-06-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Alpharetta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0107-2021