FDA recall D-0880-2021

Product

Z-107 Formula Soft Tissue Healing. Contents 1000ml. For Manufacturing Use Only, REMEDY: Amygdalus Persica 10X, Arnica Montana 10X, Bellis Perennis 10X, Chromium Sulphuricum 10X, Citrus Vulgaris 10X, Derris Pinnata 13X, Franciscea Uniflora 13X, Hamamelis Virginiana 10X, Manganum Metallicum 10X, Ruta Graveolens 10X, Sarsaparilla 10X, Zincum Muriaticum 13X, Dilution Alcohol 20%. Manufactured for Optimal Health Dimensi. RX Only, Manufactured 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-0880-2021