FDA Recall D-1586-2020
CORGIOMED LLC · Mc Lean, VA
Class I — life-threatening Terminated 623 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Leafree Instant Hand Sanitizer Aloe Vera (ethyl alcohol 70% v/v), Kills 99.99% Germs, EDIBLE ALCOHOL, a) 100 mL bottles, UPC code 6970495860325, b) 300 mL bottles, UPC code 6970495860318, and c) 500 mL bottles, UPC code 6970495860301, Exclusively Distributed by: Corgiomed LLC, McLean, VA 22102, USA, Made in China.
Reason for recall
Marketed without an Approved NDA/ANDA; product labeled as Edible Alcohol rendering the product an unapproved new drug and misbranded.
Recall record
- Recall number
D-1586-2020- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- NC and MD
- Recall initiated
- 2020-09-03
- Classified by FDA Center
- 2020-09-18
- FDA published
- 2020-09-30
- Terminated
- 2022-05-19
- Recalling firm
- CORGIOMED LLC
- Firm location
- Mc Lean, VA