FDA recall D-0886-2021

Product

ZTE-1035 Formula, Antimicrobial Combination, Contents 1006 ml, REMEDY: Arsenicum Album 10X, Baptista Tinctoria 10X, Phosphorus 10X, Arnica Montana 10X, Bryonia Alba 10X, Antimonium Crudum 10X, Iodium 10X, Lycopodium Clavatum 10X, Pulsatilla 10X, Berberis Vulgaris 10X, Glycyrrhiza Clabra 10X, Condurango 10X, Ginco Biloba 10X, Zincum Muriaticum 13X, Chromium Sulphuricum 10X, Manganum Metallicum 10X, Alfalfa 3X, Dilution Alcohol 20%, Manufactured by: Washington Homeopathic Products 260 JR Hawvernale Way, Berkeley Springs, WV, 225411, Manufactured for Optimal Health Dimensions, Washington Homeopathic Products, Inc. 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-0886-2021