Klean Touch Hand Sanitizer (Ethyl Alcohol 70%) Ingredients Ethanol and Methanol, in 55-gallon drums, Aroma Release Techn
Summary
The FDA issued a Class I for Klean Touch Hand Sanitizer (Ethyl Alcohol 70%) Ingredients Ethanol and Methanol, by Aroma Release Technologies Inc. Reason: Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol.
Details
Source
Drug Recall
External ID
D-0298-2022
Action Date
2022-01-05
Status
Terminated
Category
drug
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/Code Info: Lots: 1620-1, 1620-3, 1620-4, 1820-4, 1820-5, 1920-1, 1920-2, No Expiration Date
Quantity Affected: 37 55-gallon drums
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-30
Company
Chattanooga, TN
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 51 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Aroma Release Technologies Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Aroma Release Technologies Inc have FDA actions?
This is the only FDA action we have on record for Aroma Release Technologies Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0298-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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