Drug 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.
D-1586-2020
Product summary
- Firm
- CORGIOMED LLC
- Event
- Event 86390
- Status
- Terminated
- Classification
- Class I
- Quantity
- 28900 bottles
- Official record key
drug-enforcement:D-1586-2020
Official wording
Reason: Marketed without an Approved NDA/ANDA; product labeled as Edible Alcohol rendering the product an unapproved new drug and misbranded.
Code information: Lot # 2020A3010, Exp 05/30/2022
Distribution pattern: NC and MD
Derived failure modes
-
Labeling or packaging
misbranded