FDA recall D-0888-2021

Washington Homeopathic Products, Inc. · Class II · drug

Product

ZTE 1015 Formula, Contents 1000 ml, For Manufacturing Use only, REMEDY: Argentum Nitricum 10X, Rhus Toxicodendron 10X, Aurum Metallicum 10X, Iris Versicolor 10X, Lycopodium Clavatum 10X, Zincum Muriaticum 13X, Chromium Sulphuricum 10X, Manganum Metallicum 10X, Dilution Alcohol 20%, Manufactured for Optimal Health Dimensions, Manufactured by: Washington Homeopathic Products 260 JR Hawvernale 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-0888-2021