Why it was recalled
Marketed without an Approved NDA/ANDA: Product marketed with drug claims.
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.
Lot numbers, UPCs & expiration codes
Lot #s: 200407, 200413, 200420, 200602, 200608.
Where it was sold
Nationwide in the U.S.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0107-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 18, 2020
- FDA report date
- Dec 2, 2020
- Quantity
- 5000 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fusion Health and Vitality LLC
Original FDA data
Every field from FDA enforcement report D-0107-2021, exactly as published.
Show all FDA fields
- City
- Alpharetta
- State
- GA
- Status
- Terminated
- Country
- United States
- Event ID
- 86834
- Address
- 1360 Union Hill Rd
- Address (line 2)
- 11B
- Code information
- Lot #s: 200407, 200413, 200420, 200602, 200608.
- Postal code
- 30004-8433
- Report date
- Dec 2, 2020
- Product type
- Drugs
- Recall number
- D-0107-2021
- Classification
- Class II
- Recalling firm
- Fusion Health and Vitality LLC
- Product quantity
- 5000 bottles
- Termination date
- Jun 2, 2023
- Reason for recall
- Marketed without an Approved NDA/ANDA: Product marketed with drug claims.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the U.S.
- Recall initiation date
- Nov 18, 2020
- Initial firm notification
- Letter
- Center classification date
- Nov 25, 2020