PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: October 10, 2018 Initiated: August 31, 2018 #D-0002-2019

Product Description

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

Reason for Recall

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.

Details

Recalling Firm
BioLyte Laboratories, LLC
Units Affected
a) 500 sample packs; b) 672 bottles
Distribution
Nationwide in the USA
Location
Grand Rapids, MI

Frequently Asked Questions

What product 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. Recalled by BioLyte Laboratories, LLC. Units affected: a) 500 sample packs; b) 672 bottles.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 10, 2018. Severity: Moderate. Recall number: D-0002-2019.