Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor,
Summary
The FDA issued a Class II for Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol by ARG Laboratories, Inc.. Reason: Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process..
Details
Source
Drug Recall
External ID
D-0524-2024
Action Date
2024-06-05
Status
Ongoing
Category
drug
Product Description
Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Tube, NET WT 8 oz (226.79g), Made in the USA, painwizard.com PO Box 1099, Johnstown, CO 80534, UPC 8 63865 00011 6
Lot/Code Info: Lots 19823C4, EXP 07/31/2025; 01623C1, Exp 01/31/2025
Quantity Affected: 7,410
Reason for Recall
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Distribution
Distributed Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-17
Company
Dallas, TX
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 115 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
ARG Laboratories, Inc. has 11 FDA actions in our database, including 11 recalls.
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 (ARG Laboratories, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ARG Laboratories, Inc. have FDA actions?
ARG Laboratories, Inc. has 11 FDA actions in our database, including 11 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0524-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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