Drug recall D-0002-2019

Class II Terminated reported Oct 10, 2018

Product

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.

Lots and codes

Lot #: a) 1146, Exp 3/29/20; b) 1138, 1139, Exp 1/31/20; and 1160, Exp 10/10/19

Recall details

Recalling firm
BioLyte Laboratories, LLC, Grand Rapids, MI
Quantity
a) 500 sample packs; b) 672 bottles
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
August 31, 2018
Terminated
August 31, 2020

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