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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, Gallon Jug 128 fl. oz. (3776 ml), Manufactured for Golden Tiger LLC, Made in USA, UPC 1 82294 00005 5

D-0521-2024

April 17, 2024

Class II

Product summary

Firm
ARG Laboratories, Inc.
Event
Event 94354
Status
Ongoing
Classification
Class II
Quantity
192
Official record key
drug-enforcement:D-0521-2024

Official wording

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

Code information: Lot: 01823C2, 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