Klean Touch Hand Sanitizer (Ethyl Alcohol 70%) Ingredients Ethanol and Methanol, in 55-gallon dru...
FDA Recall #D-0298-2022 — Class I — November 30, 2021
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
Recalling Firm
Aroma Release Technologies Inc — Chattanooga, TN
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
37 55-gallon drums
Distribution
Distributed in the states of Texas and New York.
Code Information
Lots: 1620-1, 1620-3, 1620-4, 1820-4, 1820-5, 1920-1, 1920-2, No Expiration Date
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated