FDA recall D-0883-2021

Washington Homeopathic Products, Inc. · Class II · drug

Product

Z-1050 Formula Hepatodetox. Contents 1000ml. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY: Cholesterinum 10X, Avena Sativa 12X, Cynara Scolymos 12X, Phosphorus 12X, Oroticum Acidum 13X, Aesculus Hipposcastanum 24X, Carduus Marianus 24X, Chelidonium Majus 24X, Cimicifuga Racemosa 24X, Cinchona Officinalis 24X, Colocynthis 24X, Histaminum Hydrochloricum 24X, Lycopodium Clavatum 24X, Sulphur 24X, Tataxacum Officinale 24X, Veratrum Album 24X, Sepia 30X, Strontium Carbonicum 30X, Dilution Alcohol 20%. Manufactured for Optimal Health Dimensions. RX Only. anufactured by Washington Homeopathic Products, Inc. 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-0883-2021