Drug & medication recalls Moderate risk

NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel recalled over manufacturing violations

Recall date
August 31, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
BioLyte Laboratories, LLC recalls NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel, packaged in a) 4 ml sample packs and b) Net Wt. 2…
Recall number
D-0002-2019
FDA classification
Class II
Brand / firm
BioLyte Laboratories, LLC
Sold / distributed
Nationwide in the USA

Why it was recalled

CGMP Deviations: finished product produced with active ingredients recalled by the manufacturer, King Bio Inc., due to water contamination issues that could potentially affect the quality of this product.

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

What was recalled

NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel, packaged in a) 4 ml sample packs and b) Net Wt. 2.0 oz (56.7g) bottles, BioLyte Laboratories - Grand Rapids, MI 49534, NDC 58368-002-02

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