Drug & medication recalls High risk

Aroma Release Technologies Inc recalls Klean Touch Hand Sanitizer (Ethyl Alcohol 70%) Ingredients Ethanol and Methanol, in 55-gallon drums, Aroma Release Tech…

Recall date
November 30, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0298-2022
FDA classification
Class I
Brand / firm
Aroma Release Technologies Inc
Sold / distributed
Distributed in the states of Texas and New York.

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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

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