FDA Alerts Consumers of BioLyte Laboratories Voluntary Recall of NeoRelief
[9/14/2018] The Food and Drug Administration is alerting consumers and health care professionals about a voluntary recall of certain lots (1138, 1139, 1146, and 1160) of NeoRelief distributed by BioLyte Laboratories (Grand Rapids, Michigan). NeoRelief is labeled as a homeopathic topical for the temporary relief of occasional muscle cramps, restlessness and twitching and is being recalled due to microbial contamination at the active ingredient manufacturing facility.
Administration or use of drug products with microbial contamination could potentially result in increased infections that may require medical intervention.
Some of NeoReief’s active ingredients were manufactured at a King Bio Inc. facility in Asheville, North Carolina. Previously, FDA alerted consumers of HelloLife’s voluntary recall of drug products labeled as homeopathic and Beaumont Bio Med’s voluntary recall of all water- and alcohol-based products, which are also manufactured by King Bio.
Health care professionals and patients are encouraged to report any adverse events associated with Beaumont’s drug products to the FDA’s MedWatch Adverse Event Reporting program:
- Complete and submit the report online atwww.fda.gov/medwatch/report.htm; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.