FDA Recall D-0298-2022

Aroma Release Technologies Inc · Chattanooga, TN

Class I — life-threatening Terminated 836 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

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

Lot / code: Lots: 1620-1, 1620-3, 1620-4, 1820-4, 1820-5, 1920-1, 1920-2, No Expiration Date

Quantity: 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

Recall record

Recall number: D-0298-2022
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Distributed in the states of Texas and New York.
Recall initiated: 2021-11-30
Classified by FDA Center: 2021-12-28
FDA published: 2022-01-05
Terminated: 2024-03-15
Recalling firm: Aroma Release Technologies Inc
Firm location: Chattanooga, TN

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