Neorelief For Muscle Crampling And Restlessness Gel
FDA Recall NDC 58368-002
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Neorelief For Muscle Crampling And Restlessness (NDC 58368-002). A significant event, classified as Class II, was initiated on Aug 31, 2018 by Biolyte Laboratories, Llc. The reported reason for this action was: "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."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
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.
Aug 31, 2018
Oct 10, 2018
a) 500 sample packs; b) 672 bottles
Recall Profile & Regulatory Data
Event ID
81011
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
BioLyte Laboratories, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Aug 31, 2020
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
Batch or Lot Expiration Information
Lot# : a) 1146, Exp 3/29/20; b) 1138, 1139, Exp 1/31/20; and 1160, Exp 10/10/19
Affected Packages Involved in this Recall
58368-002-02Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
