FDA recall D-0298-2022

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

Reason for recall

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

Distribution

Distributed in the states of Texas and New York.

Key facts

Status

Terminated

Initiation date

2021-11-30

Report date

2022-01-05

Termination date

2024-03-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Chattanooga, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0298-2022