BioLyte Laboratories Issues Voluntary Nationwide Recall Due to the Voluntary Nationwide Recall initiated by King Bio Inc. (a Raw Material Supplier) for NeoRelief for Muscle Cramping and Restlessness Topical Gel Due to Possible Microbial Contamination

BioLyte Laboratories is voluntarily recalling lot numbers 1138, 1139, 1146, and 1160 of NeoRelief for Muscle Cramping and Restlessness Topical Gel to the retail and consumer level. King Bio Inc., a manufacturer of some of the active ingredients in this product, has been found to have some water contamination issues that potentially could have affected this product. King Bio has issued a recall of these active ingredients in BioLyte’s lot specific product. To date, there have been no reports of illness or injury due to the use of this product.

The administration or use of drug products with microbial contamination could potentially result in increased infections that may require medical intervention and could result in infections that could be life threatening to certain individuals.

Lot Number	Expiry	UPC	Size	Package type
1138	1/31/2020	358368002021	2 oz	white airless pump bottle
1139	1/31/2020	358368002021	2 oz	white airless pump bottle
1146	3/29/2020	358368002045	4 ml	4” x 2” mylar foil pack
1160	10/10/2019	358368002021	2 oz	white airless pump bottle

NeoRelief for Muscle Cramping and Restlessness (package examples are attached)

BioLyte Laboratories is notifying its retail partners, distributors and customers by letter and is arranging for return and replacement of the recalled product.

Consumers/distributors/retailers that have this product which is being recalled should discontinue use/distribution and contact BioLyte Laboratories at [email protected] to make arrangements to return the product. These products were distributed Nationwide to retailers (doctor offices, pharmacies, health food stores) and consumers (expo’s, direct sales, website) between February 7, 2017 through August 30, 2018.

Consumers with questions regarding this recall can contact BioLyte Laboratories, LLC at 800- 538-1455 Ext. 1 or e-mail [email protected], Monday – Friday 7:30 am – 3:30 pm EST. Consumers should contact their physician or healthcare provider if they believe they have experienced any problems that may be related to using this product.

Adverse reactions or quality problems associated with the use of this product may be reported to FDA’s MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.

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