FDA Drug Moderate Class II Terminated

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.

Reported: November 27, 2019 Initiated: November 8, 2019 #D-0506-2020

Product Description

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.

Details

Recalling Firm: Washington Homeopathic Products, Inc.
Units Affected: a) 1 bottle; b) 11 bottles
Distribution: Product was distributed Nationwide throughout the United States, Canada and Saudi Arabia
Location: Berkeley Springs, WV

Frequently Asked Questions

What product 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.. Recalled by Washington Homeopathic Products, Inc.. Units affected: a) 1 bottle; b) 11 bottles.

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on November 27, 2019. Severity: Moderate. Recall number: D-0506-2020.

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