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Recall Observatory FDA recall evidence

Drug product

Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Bottle with pump, NET WT 16 fluid oz / 473.17 ml, Made in USA, www.painwizard.com Pain Wizard LLC.PO Box 1099, Johnstown, CO 80534, UPC 8 63865 00012 3

D-0520-2024

April 17, 2024

Class II

Product summary

Firm
ARG Laboratories, Inc.
Event
Event 94354
Status
Ongoing
Classification
Class II
Quantity
3,440
Official record key
drug-enforcement:D-0520-2024

Official wording

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

Code information: Lot: 18723C3, Exp 06/30/2025

Distribution pattern: Distributed Nationwide in the USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out of Specification