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Recall Observatory FDA recall evidence

Drug product

ZTE-1035 Formula, Antimicrobial Combination, Contents 1006 ml, REMEDY: Arsenicum Album 10X, Baptista Tinctoria 10X, Phosphorus 10X, Arnica Montana 10X, Bryonia Alba 10X, Antimonium Crudum 10X, Iodium 10X, Lycopodium Clavatum 10X, Pulsatilla 10X, Berberis Vulgaris 10X, Glycyrrhiza Clabra 10X, Condurango 10X, Ginco Biloba 10X, Zincum Muriaticum 13X, Chromium Sulphuricum 10X, Manganum Metallicum 10X, Alfalfa 3X, Dilution Alcohol 20%, Manufactured by: Washington Homeopathic Products 260 JR Hawvernale Way, Berkeley Springs, WV, 225411, Manufactured for Optimal Health Dimensions, Washington Homeopathic Products, Inc. 260 JR Hawvernale Way, Berkeley Springs, WV, 25411,

D-0886-2021

August 20, 2021

Class II

Product summary

Firm
Washington Homeopathic Products, Inc.
Event
Event 88528
Status
Terminated
Classification
Class II
Quantity
2 1/liter
Official record key
drug-enforcement:D-0886-2021

Official wording

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

Code information: Lot # 25697, no expiry date

Distribution pattern: Distributed Nationwide in the USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out-of-specification