PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: January 5, 2022 Initiated: November 30, 2021 #D-0298-2022

Product Description

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

Reason for Recall

Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol

Details

Units Affected
37 55-gallon drums
Distribution
Distributed in the states of Texas and New York.
Location
Chattanooga, TN

Frequently Asked Questions

What product was recalled?
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. Recalled by Aroma Release Technologies Inc. Units affected: 37 55-gallon drums.
Why was this product recalled?
Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
Which agency issued this recall?
This recall was issued by the FDA Drug on January 5, 2022. Severity: Critical. Recall number: D-0298-2022.