ZTE-1034 Formula Antimicrobial Bowel. Contents 1000ml. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY: Ars
Summary
The FDA issued a Class II for ZTE-1034 Formula Antimicrobial Bowel. Contents 1000ml. WHP Homeopathic Medicine, by Washington Homeopathic Products, Inc.. Reason: Out-of-specification test results obtained for identification testing based on HPTLC analysis..
Details
Source
Drug Recall
External ID
D-0885-2021
Action Date
2021-10-06
Status
Terminated
Category
drug
Product Description
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.
Lot/Code Info: Lot # 25887, Exp 8/17/2026
Quantity Affected: 2/1 Liter bottles
Reason for Recall
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Distribution
Distributed Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-20
Company
Berkeley Springs, WV
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 107 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Washington Homeopathic Products, Inc. has 57 FDA actions in our database, including 57 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Washington Homeopathic Products, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Washington Homeopathic Products, Inc. have FDA actions?
Washington Homeopathic Products, Inc. has 57 FDA actions in our database, including 57 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0885-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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