D-1586-2020 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 30, 2020
- Initiation Date
- September 3, 2020
- Termination Date
- May 19, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28900 bottles
Product Description
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.
Distribution Pattern
NC and MD
Code Information
Lot # 2020A3010, Exp 05/30/2022