November 2021 FDA Recall Drug by Aroma Release Technologies Inc
D-0298-2022 - Marketed Without an Approved NDA/ANDA

This Class I drug recall was voluntarily initiated by Aroma Release Technologies Inc on November 30, 2021 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed in Distributed in the states of Texas and New York. and the recall is currently terminated.

Recall Number: D-0298-2022

Reason for Recall
Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
Initiated
11-30-2021
Reported
01-05-2022
Quantity
37 55-gallon drums

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89138
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.
Aroma Release Technologies Inc
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed in the states of Texas and New York.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-15-2024
Product Description About Product Description
Full technical description of the product.
Klean Touch Hand Sanitizer (Ethyl Alcohol 70%) Ingredients Ethanol and Methanol, in 55-gallon drums, Aroma Release Technology, Inc., 7026 Discovery Drive, Chattanooga, TN 37416

Batch or Lot Expiration Information

Lot# Lots: 1620-1, 1620-3, 1620-4, 1820-4, 1820-5, 1920-1, 1920-2, No Expiration Date