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Recall Observatory FDA recall evidence

Drug product

ZTE-1034 Formula Antimicrobial Bowel. Contents 1000ml. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY: Arsenicum Album 10X, Baptisia Tinctoria 10X, Pulsatilla 10X, Lachesis Mutus 11X, Rhus Toxicodendron 10X, Belladonna 7X, Colchicum Autumnale 5X, Aconitum Napellus 8X, Astragalus Menziesli 8X, Carbo Vegetabilis 8X, Chamomilla 3X, Hydrastis Canadensis 3X, Echinacea Angustifolia 12X, Pulsatilla 11X, Anas Barariae, Hepatis ET 60C, Anas Barariae, Hepatis ET 100C, Anas Barariae, Hepatis ET 200C, Carduus Marianus 6X, Taraxacum Officinale 4X, Berberis Aquifolium 8X, Zingiber Officinal 8X, Allium Sativum 4X, Dilution Alcohol 20%. Causticum 30X, Conium Maculatum 8X, Conium Maculatum 12X, Crataegus Oxyacantha 12X, Crataegus Oxyacantha 30X, Ignatia Amara 24X, Lycopus Virginicus 12X, Phosphoricum Acidum 12X, Phosphoricum Acidum 24X, Rhus Toxicodendron 24X, Secale Cornutum 24X, Secale Cornutum 30X, Sepia 6X, Sepia 24X, Solanum Nigrum 30X, Zincum Valericanicum 8X, Zincum Valerianicum 12X, Dilution Alcohol 20%. Manufactured for Optimal Health Dimensions. RX Only. anufactured by Washington Homeopathic Products, Inc. 260 JR Hawvermale Way, Berkeley Springs, WV, 25411.

D-0885-2021

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-0885-2021

Official wording

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

Code information: Lot # 25887, 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