COMPANY ANNOUNCEMENT
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
This recall has been completed and FDA has terminated this recall.
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.
Read Announcement View Product PhotosSummary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Drugs
- Reason for Announcement:
-
Recall Reason DescriptionDue to Possible Microbial Contamination
- Company Name:
- BioLyte Laboratories
- Brand Name:
-
Brand Name(s)NeoRelief
- Product Description:
-
Product DescriptionMuscle
Company 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 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 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 experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
