FDA recall D-1586-2020

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.

Distribution

NC and MD

Key facts

Status

Terminated

Initiation date

2020-09-03

Report date

2020-09-30

Termination date

2022-05-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mc Lean, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1586-2020