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Recall Observatory FDA recall evidence

Drug product

Z-103 GU DETOXING. Contents 1000ml 20% Alcohol. WHP Homeopathic Medicine. For Manufacturing Use Only, REMEDY: Agrimonia Eupatoria 24X, Alfalfa 24X, Althaea Officinalis 24X, Avena Sativa 24X, Boldo 24X, Carduus Marianus 24X, Chioanathus Virginica 24X, Cynara Scolymus 24X, Iria Versicolor 24X, Millefolium 24X, Rumex Crispus 24X, Selenium Metallicum 12X, Selenium Metallicum 60X, Solidago Virgaurea 12X, Solidago Virgaurea 24X, Solidago Virgaurea 60X, Spiraea Ulmaira 24X, Taraxacum Officinale 24X, Urtica Dioica 24X, Uva-Ursi 24X, Zincum Muriaticum 13X, Zincum Mruiaticum 30X, Dilution Alcohol 20%. Manufactured for Optimal Health Dimensi. RX Only, Manufactured by Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV, 25411.

D-0879-2021

August 20, 2021

Class II

Product summary

Firm
Washington Homeopathic Products, Inc.
Event
Event 88528
Status
Terminated
Classification
Class II
Quantity
2/1 Liter bottles
Official record key
drug-enforcement:D-0879-2021

Official wording

Reason: Out-of-specification test results obtained for identification testing based on HPTLC analysis.

Code information: Lot # 26364, Exp 8/17/2026

Distribution pattern: Distributed Nationwide in the USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out-of-specification