FDA alerts consumers, pet owners not to use products manufactured by King Bio, including Dr. King’s label, homeopathic drug and pet products
Firm recalls hundreds of water-based products for humans and pets due to microbial contamination
For Immediate Release
August 28, 2018
Release
The Food and Drug Administration is warning consumers and pet owners not to use drug products, including homeopathic drug products, made by King Bio Inc., Asheville, N.C., and labeled as Dr. King’s, as these products may pose a safety risk to people (especially infants, children, pregnant women and those with compromised immune systems), as well as pets due to high levels of microbial contamination identified at the manufacturing site. King Bio has expanded its voluntary recall for a second time to include all water-based (aqueous) drug products marketed for human and animals. The FDA recommends that consumers stop using and dispose of these products immediately.
In addition to the FDA’s concerns about the company’s recurring issues with contamination, the FDA and the Federal Trade Commission (FTC) issued a joint warning letter to King Bio in January 2018, for illegally marketing an unapproved product to prevent, cure or treat opioid addiction.
The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of King Bio’s products to the FDA’s MedWatch Adverse Event Reporting program:
- Complete and submit the report online at fda.gov/medwatch/report.htm; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
For reporting adverse drug events in animals, please see How to Report Animal Drug Side Effects and Product Problems.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.