Class I · High risk
Leafree Instant Hand Sanitizer Aloe Vera
Marketed without an Approved NDA/ANDA; product labeled as Edible Alcohol rendering the product an unapproved new drug and misbranded.
Immune Boost with natural strawberry flavor
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Marketed without an Approved NDA/ANDA: Product marketed with drug claims.
Cause type: Unapproved drug
The product was marketed without an approved NDA/ANDA, or does not meet the OTC monograph it claims to follow. Nothing about the product - dose, purity, safety - has been reviewed by FDA, so the claims on the box are unverified. All unapproved drug recalls.
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.
- Recalling firm
- Fusion Health and Vitality LLC
- Origin
- GA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0107-2021 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other unapproved drug recalls from 2020
All unapproved drug recalls
Class II · Moderate risk
pH-D Feminine Health Boric Acid Vaginal Suppositories
Marketed without an Approved NDA/ANDA.
Class I · High risk
Volu-Sol Handrub Sanitizing Solution
Marketed Without an Approved NDA/ANDA: product lists methanol as an inactive ingredient on the label.
Class II · Moderate risk
Thyro-H
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
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