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Recall Observatory FDA recall evidence

Drug product

NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Pump Capsaicin, Aloe Vera, Willow Bark & MSM, Bottle with Pump NET WT 32 fl. oz (946.33ml), Manufactured for Golden Tiger LLC Made in USA, UPC 1 82294 00004 8

D-0526-2024

April 17, 2024

Class II

Product summary

Firm
ARG Laboratories, Inc.
Event
Event 94354
Status
Ongoing
Classification
Class II
Quantity
500
Official record key
drug-enforcement:D-0526-2024

Official wording

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

Code information: Lot 01823C2, 01823C1, Exp 01/31/2025

Distribution pattern: Distributed Nationwide in the USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out of Specification