FDA alerts consumers of HelloLife’s voluntary recall of Neuroveen, Respitrol, Thyroveev and Compulsin
[8/31/2018] The Food and Drug Administration is alerting consumers and health care professionals to a voluntary recall of certain lots of HelloLife (Grand Rapids, Michigan) drug products, Neuroveen, Respitrol, Thyroveev and Compulsin. The products labeled as homeopathic are being recalled due to microbial contamination.
According to HelloLife, Neuroveen was tested and found to be contaminated with Staphylococcus saprophyticus and Burkholderia cepacia. Compulsin was tested and found to be contaminated with Burkholderia cepacia. Respitrol and Thyroveev are still pending bacterial identification.
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.
These products were manufactured at the King Bio, Inc. facility in Asheville, North Carolina.
Health care professionals and patients are encouraged to report any adverse events associated with HelloLife’s drug products to the FDA’s MedWatch Adverse Event Reporting program:
- Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.