FDA recall D-0858-2021

Washington Homeopathic Products, Inc. · Class II · drug

Product

ZTE-105 Formula Gentle Detoxing. Contents 1000 mL, RX Only, REMEDY: Bryoni Alba 10X, Chelidonium Majus 10X, Carduus Marianus 10X, Dolichos Pruriens 10X, Solidago Vigaurea 10X, Alfalfa 10X, Boldo 10X, Cynara Scolymus 10X, Zincum Muriaticum 13X, Chromium Sulphuricum 10X, Manganum Metallicum 10X, Dilution Alcohol 20%. WHP Homeopathic Medicine. For Manufacturing Use Only, Manufactured for Optimal Health Dimensi. 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-0858-2021