Drug & medication recalls Moderate risk

Washington Homeopathic Products product recalled over manufacturing violations

Recall date
November 8, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Washington Homeopathic Products, Inc. recalls R2103, Active Ingredients: Berberis Aquifolium 3x; Borax 3; , Kreosotum 10X; Sepia 3x. Inactive ingredient: 28% dilutio…
Recall number
D-0506-2020
FDA classification
Class II
Brand / firm
Washington Homeopathic Products, Inc.
Sold / distributed
Product was distributed Nationwide throughout the United States, Canada and Saudi Arabia

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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