Class I
Terminated
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.
This recall has been terminated (originally issued September 30, 2020).
- Company
- Corgiomed Llc
- Recall Initiated
- September 3, 2020
- Posted
- September 30, 2020
- Recall Number
- D-1586-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 28900 bottles
- Firm Location
- Mc Lean, VA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Marketed without an Approved NDA/ANDA; product labeled as Edible Alcohol rendering the product an unapproved new drug and misbranded.
Distribution
NC and MD
Lot / Code Info
Lot # 2020A3010, Exp 05/30/2022
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