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Recall Observatory FDA recall evidence

Drug product

Premier Value, Fast Relief, Muscle Rub, (menthol 10% and methyl salicylate 15%) 4 OZ (113 g) tube, Distributed By: Chain Drug Consortium, 3301 NW Boca Raton Blvd., Suite 101, Boca Raton, FL, 33431, UPC 8 40986 01341

D-0068-2019

August 03, 2018

Class II

Product summary

Firm
Product Quest Manufacturing LLC
Event
Event 80750
Status
Terminated
Classification
Class II
Quantity
4,692 tubes
Official record key
drug-enforcement:D-0068-2019

Official wording

Reason: Superpotent Drug: high out of specification assay results for the menthol ingredient.

Code information: Lot. 172598G, Exp. 7/4/2019

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Superpotent