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Recall Observatory FDA recall evidence

Drug product

Z-107 Formula Soft Tissue Healing. Contents 1000ml. For Manufacturing Use Only, REMEDY: Amygdalus Persica 10X, Arnica Montana 10X, Bellis Perennis 10X, Chromium Sulphuricum 10X, Citrus Vulgaris 10X, Derris Pinnata 13X, Franciscea Uniflora 13X, Hamamelis Virginiana 10X, Manganum Metallicum 10X, Ruta Graveolens 10X, Sarsaparilla 10X, Zincum Muriaticum 13X, Dilution Alcohol 20%. Manufactured for Optimal Health Dimensi. RX Only, Manufactured by Washington Homeopathic Products, Inc. 260 JR Hawvermale Way, Berkeley Springs, WV, 25411.

D-0880-2021

August 20, 2021

Class II

Product summary

Firm
Washington Homeopathic Products, Inc.
Event
Event 88528
Status
Terminated
Classification
Class II
Quantity
2 1/liter bottle
Official record key
drug-enforcement:D-0880-2021

Official wording

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

Code information: Lot # 27668, 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