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Recall Observatory FDA recall evidence

Drug product

NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Roll-On NET WT 3 fl. oz. (88.7ml), Manufactured for Golden Tiger USA Albuquerque, NM, UPC 1 82294 00006 2

D-0529-2024

April 17, 2024

Class II

Product summary

Firm
ARG Laboratories, Inc.
Event
Event 94354
Status
Ongoing
Classification
Class II
Quantity
1,680
Official record key
drug-enforcement:D-0529-2024

Official wording

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

Code information: Lot 17323C3, 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