FDA recall D-0506-2020

Product

R2103, Active Ingredients: Berberis Aquifolium 3x; Borax 3; , Kreosotum 10X; Sepia 3x. Inactive ingredient: 28% dilution alcohol, packaged in a) 470 mL bottle and b) 1000 mL bottle; Manufactured for Wisconsin Pharmacal Company, By: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411.

Reason for recall

CGMP Deviations: products were not manufactured under current good manufacturing practices.

Distribution

Product was distributed Nationwide throughout the United States, Canada and Saudi Arabia

Key facts

Status

Terminated

Initiation date

2019-11-08

Report date

2019-11-27

Termination date

2023-01-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Berkeley Springs, WV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0506-2020