[10/4/2018] The Food and Drug Administration is alerting consumers and pet owners about a voluntary recall of certain lots of eight products – six products for humans, including four Native Remedies and two Healthful Naturals, and two PetAlive products for pets – distributed by Silver Star Brands Inc. (Oshkosh, Wisconsin). These products are labeled as a homeopathic and are being recalled due to microbial contamination at the King Bio Inc. manufacturing facility in Asheville, North Carolina.
Administration or use of drug products with microbial contamination could potentially result in increased infections that may require medical intervention.
Previously, FDA alerted consumers to three other voluntary recalls related to King Bio’s recall:
- HelloLife’s voluntary recall of drug products labeled as homeopathic;
- Beaumont Bio Med’s voluntary recall of all water- and alcohol-based products; and
- BioLyte Laboratories voluntary recall of NeoRelief
Health care professionals and patients should report any adverse events associated with Silver Star’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.
Pet owners and veterinarians are encouraged to report animal adverse drug events by following the directions for How to Report Animal Drug Side Effects and Product Problems.