FDA recall D-0879-2021

Washington Homeopathic Products, Inc. · Class II · drug

Product

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.

Reason for recall

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

Distribution

Distributed Nationwide in the USA

Key facts

Status
Terminated
Initiation date
2021-08-20
Report date
2021-10-06
Termination date
2022-06-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Berkeley Springs, WV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0879-2021