Klean Touch Hand Sanitizer Recalled: Unapproved Methanol-Containing Drug
Aroma Release Technologies Inc is recalling Klean Touch Hand Sanitizer (Ethyl Alcohol 70%) in 55-gallon drums because the product contains methanol and was marketed without FDA approval as a new drug.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall is classified as FDA Class I by the agency. Class I recalls are serious health hazards and require a severity score of at least 4. Methanol is a toxic substance that poses significant risk of harm through skin absorption and inhalation, particularly in a hand sanitizer product intended for frequent use.
Plain-English summary
Aroma Release Technologies Inc is recalling Klean Touch Hand Sanitizer (Ethyl Alcohol 70%) distributed in 55-gallon drums. The product is labeled to contain methanol, making it an unapproved new drug under FDA regulations.
The affected product was distributed in Texas and New York. The recalled lot numbers are: 1620-1, 1620-3, 1620-4, 1820-4, 1820-5, 1920-1, and 1920-2. A total of 37 drums are subject to this recall. The product has no expiration date listed.
Consumers who have purchased this hand sanitizer should stop using it immediately and contact Aroma Release Technologies Inc or their supplier for instructions on return or disposal.
The recalled product
- 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
- Manufacturer
- Aroma Release Technologies Inc
- Category
- Drug — Topical / Hand Sanitizer
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Lots: 1620-1
- 1620-3
- 1620-4
- 1820-4
- 1820-5
- 1920-1
- 1920-2
- No Expiration Date
Distribution
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