FDA Recall D-0524-2024

ARG Laboratories, Inc. · Dallas, TX

Class II Ongoing 757 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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: Lots 19823C4, EXP 07/31/2025; 01623C1, Exp 01/31/2025

Quantity: 7,410

Reason for recall

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

Recall record

Recall number: D-0524-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Distributed Nationwide in the USA
Recall initiated: 2024-04-17
Classified by FDA Center: 2024-05-30
FDA published: 2024-06-05
Recalling firm: ARG Laboratories, Inc.
Firm location: Dallas, TX

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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