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Recall Observatory FDA recall evidence

Drug product

Koala Hand Sanitizer, Soothing Eucalyptus, 16 FL OZ., Antibacterial, (Ethyl Alcohol 68%), Manufactured by Beaming White LLC, 1205 NE 95th St., Vancouver, WA 98665

D-1357-2020

June 12, 2020

Class II

Product summary

Firm
Beaming White Llc
Event
Event 85784
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-1357-2020

Official wording

Reason: Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.

Code information: Lot #: 40820, Exp. Date 4/8/23

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent