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Recall Observatory FDA recall evidence

Drug product

Hemp Bombs CBD Pain Freeze (menthol 4%), 100mg, 1 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634, NDC 73423-003-01; UPC Code: 8-40078-56493-2

D-0613-2024

June 25, 2024

Class III

Product summary

Firm
GLOBAL WIDGET LLC
Event
Event 94838
Status
Ongoing
Classification
Class III
Quantity
18540 bottles
Official record key
drug-enforcement:D-0613-2024

Official wording

Reason: Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.

Code information: Lot #: 230189, Exp. date Apr 2025; 230335, Exp. date Jul 2025; 230351, Exp. date Aug 2025

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent