Hemp Bombs CBD Pain Freeze (menthol 4%), 100mg, 1 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 3
Summary
The FDA issued a Class III for Hemp Bombs CBD Pain Freeze (menthol 4%), 100mg, 1 oz bottles, Distributed by: Gl by GLOBAL WIDGET LLC. Reason: Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%..
Details
Source
Drug Recall
External ID
D-0613-2024
Action Date
2024-07-31
Status
Ongoing
Category
drug
Product Description
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
Lot/Code Info: Lot #: 230189, Exp. date Apr 2025; 230335, Exp. date Jul 2025; 230351, Exp. date Aug 2025
Quantity Affected: 18540 bottles
Reason for Recall
Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2024-06-25
Company
Tampa, FL
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 39 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
GLOBAL WIDGET LLC has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (GLOBAL WIDGET LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GLOBAL WIDGET LLC have FDA actions?
GLOBAL WIDGET LLC has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0613-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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