FDA recall D-0002-2019

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.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2018-08-31

Report date

2018-10-10

Termination date

2020-08-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Grand Rapids, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0002-2019