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Recall Observatory FDA recall evidence

Drug product

Soothing Sore Relief (lidocaine) Liquid Gel, 4%, packaged in a) 1 Oz (NDC 69804-077-14), b) 2 Oz (NDC 69804-077-15), and c) 4 Oz (NDC 69804-077-16) bottles, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301.

D-1861-2019

August 09, 2019

Class II

Product summary

Firm
Ridge Properties, LLC
Event
Event 83538
Status
Terminated
Classification
Class II
Quantity
104.1 ounces
Official record key
drug-enforcement:D-1861-2019

Official wording

Reason: Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.

Code information: Lot # 1135, Exp 12/27/2022

Distribution pattern: Nationwide in the USA via internet sales through Amazon.com; ebay.com; Walmart.com; tatbalm.net; Naturallyhl.com

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Superpotent