Z-103 GU DETOXING. Contents 1000ml 20% Alcohol. WHP Homeopathic Medicine. For Manufacturing Use Only, REMEDY: Agrimonia
Summary
The FDA issued a Class II for Z-103 GU DETOXING. Contents 1000ml 20% Alcohol. WHP Homeopathic Medicine. For Ma 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-0879-2021
Action Date
2021-10-06
Status
Terminated
Category
drug
Product Description
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.
Lot/Code Info: Lot # 26364, 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-0879-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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