Drug & medication recalls Moderate risk

Skin Irritation & Itch Response Homeopathic Formula recalled over manufacturing violations

Recall date
August 31, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Beaumont Bio-med, Inc. recalls Skin Irritation & Itch Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed…
Recall number
D-1192-2018
FDA classification
Class II
Brand / firm
Beaumont Bio-med, Inc.
Sold / distributed
Nationwide in the USA

Why it was recalled

CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

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

What was recalled

Skin Irritation & Itch Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7002-7

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