Why it was recalled
Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
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
Lot numbers, UPCs & expiration codes
Lots: 1620-1, 1620-3, 1620-4, 1820-4, 1820-5, 1920-1, 1920-2, No Expiration Date
Where it was sold
Distributed in the states of Texas and New York.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0298-2022
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Nov 30, 2021
- FDA report date
- Jan 5, 2022
- Quantity
- 37 55-gallon drums
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aroma Release Technologies Inc
Original FDA data
Every field from FDA enforcement report D-0298-2022, exactly as published.
Show all FDA fields
- City
- Chattanooga
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 89138
- Address
- 7026 Discovery Dr
- Code information
- Lots: 1620-1, 1620-3, 1620-4, 1820-4, 1820-5, 1920-1, 1920-2, No Expiration Date
- Postal code
- 37416-1692
- Report date
- Jan 5, 2022
- Product type
- Drugs
- Recall number
- D-0298-2022
- Classification
- Class I
- Recalling firm
- Aroma Release Technologies Inc
- Product quantity
- 37 55-gallon drums
- Termination date
- Mar 15, 2024
- Reason for recall
- Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Distributed in the states of Texas and New York.
- Recall initiation date
- Nov 30, 2021
- Initial firm notification
- Letter
- Center classification date
- Dec 28, 2021