September 2020 FDA Recall Drug by Corgiomed Llc
D-1586-2020 - Marketed without an Approved NDA/ANDA; product labeled as Edible Alcohol rendering the product an unapproved new drug and misbranded.

This Class I drug recall was voluntarily initiated by Corgiomed Llc on September 3, 2020 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda; product labeled as edible alcohol rendering the product an unapproved new drug and misbranded.. The product was distributed in NC and MD and the recall is currently terminated.

Recall Number: D-1586-2020

Reason for Recall
Marketed without an Approved NDA/ANDA; product labeled as Edible Alcohol rendering the product an unapproved new drug and misbranded.
Initiated
09-03-2020
Reported
09-30-2020
Quantity
28900 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86390
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
CORGIOMED LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NC and MD
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2022
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 2020A3010, Exp 05/30/2022