Drug 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
D-0298-2022
Product summary
- Event
- Event 89138
- Status
- Terminated
- Classification
- Class I
- Quantity
- 37 55-gallon drums
- Official record key
drug-enforcement:D-0298-2022
Official wording
Reason: Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
Code information: Lots: 1620-1, 1620-3, 1620-4, 1820-4, 1820-5, 1920-1, 1920-2, No Expiration Date
Distribution pattern: Distributed in the states of Texas and New York.
Derived failure modes
-
Foreign material or chemical contamination
contain methanol