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Recall Observatory FDA recall evidence

Drug product

Hemp Bombs CBD Pain Freeze (menthol 4%), 400mg, 4 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634; UPC code: 8-40078-56497-0

D-0615-2024

June 25, 2024

Class III

Product summary

Firm
GLOBAL WIDGET LLC
Event
Event 94838
Status
Ongoing
Classification
Class III
Quantity
11130 bottles
Official record key
drug-enforcement:D-0615-2024

Official wording

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

Code information: Lot #: 220364, Exp. date Oct 2024; 230424, Exp. date Sep 2025

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent