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Recall Observatory FDA recall evidence

Drug product

Handese Advanced Instant Hand Sanitizer (Ethyl Alcohol 70%), 12 FL OZ (354 mL) bottles, www.handeseclean.com UPC 612520481094

D-1411-2020

June 01, 2020

Class II

Product summary

Firm
WORLD EVENT PROMOTIONS, LLC
Event
Event 85926
Status
Terminated
Classification
Class II
Quantity
14050 bottles
Official record key
drug-enforcement:D-1411-2020

Official wording

Reason: Subpotent Drug: Product was found to be subpotent. Product also has high pH levels

Code information: All Lots

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent