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Recall Observatory FDA recall evidence

Drug 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

D-0298-2022

November 30, 2021

Class I

Product summary

Firm
Aroma Release Technologies Inc
Event
Event 89138
Status
Terminated
Classification
Class I
Quantity
37 55-gallon drums
Official record key
drug-enforcement:D-0298-2022

Official wording

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

Code information: Lots: 1620-1, 1620-3, 1620-4, 1820-4, 1820-5, 1920-1, 1920-2, No Expiration Date

Distribution pattern: Distributed in the states of Texas and New York.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    contain methanol