Drug 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.
D-0107-2021
Product summary
- Event
- Event 86834
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5000 bottles
- Official record key
drug-enforcement:D-0107-2021
Official wording
Reason: Marketed without an Approved NDA/ANDA: Product marketed with drug claims.
Code information: Lot #s: 200407, 200413, 200420, 200602, 200608.
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Unknown
Marketed without an Approved NDA/ANDA: Product marketed with drug claims.