Safety

Company Announcement

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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

For Immediate Release

September 12, 2018

Contact

Consumers

support@biolytelabs.com
800- 538-1455 Ext. 1

Announcement

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 NumberExpiryUPCSizePackage type
11381/31/20203583680020212 ozwhite airless pump bottle
11391/31/20203583680020212 ozwhite airless pump bottle
11463/29/20203583680020454 ml4” x 2” mylar foil pack
116010/10/20193583680020212 ozwhite 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 support@biolytelabs.com 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 support@biolytelabs.com, 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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Product Photos

“Product image, NeoRelif muscle cramping & restlessness, 2018 Current Bottle, Label, and Box Design”

“Product image, front of NeoRelif muscle cramping & restlessness, 2017 Sample Pack”

“Product image, back of NeoRelif muscle cramping & restlessness, 2017 Sample Pack”

“Product image, front of NeoRelif muscle cramping & restlessness, Feb 2017 through April 2018 Label Design”

“Product image, back of NeoRelif muscle cramping & restlessness, Feb 2017 through April 2018 Label Design”

“Product image, base of NeoRelif muscle cramping & restlessness, Feb 2017 through April 2018 Label Design”

Page Last Updated: 09/13/2018
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