Cooling Menthol Extra Strength Pain Relief Patch, Menthol 7.5%, packaged in box of 5, Distributed by J.R. Watkins LLC, O
Summary
The FDA issued a Class II for Cooling Menthol Extra Strength Pain Relief Patch, Menthol 7.5%, packaged in box by JR Watkins. Reason: cGMP Deviations.
Details
Source
Drug Recall
External ID
D-0075-2025
Action Date
2024-12-04
Status
Terminated
Category
drug
Product Description
Cooling Menthol Extra Strength Pain Relief Patch, Menthol 7.5%, packaged in box of 5, Distributed by J.R. Watkins LLC, Oakland CA 94612 UPC 8 56294 00878 5, NDC 72342-100-05
Lot/Code Info: Lot # JC101, JC102 and JC103, exp. date Oct 31, 2025
Quantity Affected: 7,138 patches
Reason for Recall
cGMP Deviations
Distribution
Nationwide in the US
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-01
Company
Bristol, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 55 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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 (JR Watkins) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does JR Watkins have FDA actions?
This is the only FDA action we have on record for JR Watkins in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0075-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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