Drugs and homeopathic products manufactured by King Bio Inc. (Asheville, NC) may contain high levels of microbial contamination and pose a risk to humans and pets.
In an alert posted today, FDA recommended that consumers stop using these products, and dispose of them immediately.
The FDA announcement coincided with a voluntary nationwide recall initiated by the manufacturer of all aqueous-based products for human and animal use. A complete list of recalled products has been posted on the company’s website.
This is the third product recall announced by King Bio since July 20, 2018.
Among the products included in the most recent recall are: Dr. King’s Children’s Cough Relief, Dr. King’s Chicken Pox Symptom Relief, Dr. King’s Children’s Ear Relief Formula, Dr. King’s Children’s Appetite Enhancer, Dr. King’s Attention and Learning Enhancement For Kids, Dr. King’s Cold Sore treatment, Dr. King’s Wart Freeze, and pet products for urinary incontinence and digestion relief.
The recall announcement and the associated consumer alert follow an inspection of the company’s manufacturing facility by FDA – an inspection that uncovered substandard conditions, including recurring microbial contamination associated with the water system used to manufacture the drug products.
FDA found several microbial contaminants during the course of its investigation, including Burkholderia Multivorans, a strain of bacteria that can cause illness in people with compromised immune systems.
What should consumers do?
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 www.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.