Leafree Instant Hand Sanitizer Aloe Vera recalled over labeling errors

Recall date

September 3, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

CORGIOMED LLC recalls Leafree Instant Hand Sanitizer Aloe Vera (ethyl alcohol 70% v/v), Kills 99.99% Germs, EDIBLE ALCOHOL, a) 100 mL bottles…

Recall number

D-1586-2020

FDA classification

Class I

Brand / firm

CORGIOMED LLC

Sold / distributed

NC and MD

Why it was recalled

Marketed without an Approved NDA/ANDA; product labeled as Edible Alcohol rendering the product an unapproved new drug and misbranded.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.