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Drug FDA Class II Ongoing cGMP deviation

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

ARG Laboratories, Inc. Published Jun 5, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 68/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact ARG Laboratories, Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.

Hazards

Propylene Glycol (Violative Grade) · primary

Affected products (1)

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

7,410

Lot codes: 19823C4
Code info: Lots 19823C4, EXP 07/31/2025; 01623C1, Exp 01/31/2025

Affected areas

Nationwide

Timeline

  1. Initiated
    Apr 17, 2024
  2. Published
    Jun 5, 2024
Recall number
D-0524-2024
Agency
U.S. Food and Drug Administration
Country
US

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.