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.
"We take product quality issues seriously, and when we see substandard conditions during the course of our inspections – in this case conditions that are leading to high levels of microbial contamination with the potential to harm the public -- we act swiftly to try to ensure the products are removed from circulation," said FDA Commissioner Scott Gottlieb, M.D. "In recent years, we've seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer. In addition to our concerns with contamination, some homeopathic products may not deliver any benefit and have the potential to cause harm. That's why we've taken steps in the last year to advance a new regulatory approach to prioritize additional enforcement and regulatory actions against certain homeopathic products. We're focused on products that have the greatest potential to cause risk to patients, including products for vulnerable populations like children. In the past year, we've also taken actions against homeopathic products that were making unproven drug claims."
King Bio manufactures a range of products including those for children, adults and pets. Products that are part of the recall include 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 full list of products is listed on the King Bio website.
Consumers and pets who use these products could have an increased risk of serious infection, that could require medical attention, due to the high levels of microbial contamination. An infection could be a life-threatening event for immunocompromised patients. Consumers and pet owners who have purchased these products should contact their health care professional if they have concerns or observe signs of an infection after use of these products.
The FDA recently inspected King Bio's facility and collected product samples. The FDA is currently testing and analyzing product samples collected at the facility. According to the company, several microbial contaminants were found in its products, including Burkholderia Multivorans, which is a strain of bacteria called Burkholderia cepacia complex (BCC) that can cause illness in people with compromised immune systems. Additionally, evidence collected during the FDA's inspection indicates recurring microbial contamination associated with the water system used to manufacture drug products.
King Bio voluntarily recalled three drug products labeled as homeopathic due to confirmed microbial contamination in July 2018. The company then expanded its voluntary recall to include an additional 32 drug products on August 22, 2018. The FDA contacted King Bio on August 23, 2018, and recommended the company again expand its recall to include all products that use water as an ingredient, including drug products for humans and animals. The company is expanding its recall to drug products made with water marketed for human and animals.
Products labeled as homeopathic can contain a wide range of substances, including ingredients derived from plants, healthy or diseased animal or human sources, minerals, and chemicals. These products are often marketed as natural, safe and effective alternatives to approved prescription and nonprescription products, and are sold online and in major retail stores. The FDA has not approved any products labeled as homeopathic; this means that any product labeled as homeopathic is being marketed in the U.S. without FDA evaluation for safety or effectiveness. These unapproved drugs may cause significant and even irreparable harm if they are poorly manufactured, which can lead to contamination, or contain active ingredients that aren't adequately tested or disclosed to patients, such as belladonna, which the agency has previously warned against.
Because of the increase in the marketing and use of homeopathic products that claim to treat serious diseases and conditions, as well as conditions specific to children and infants, the FDA recently proposed a new, risk-based enforcement approach for products labeled as homeopathic in December 2017. Under the proposed new approach, the agency stated it would intend to focus its enforcement authorities on products that have the potential to cause risk to patients, including those with reported safety concerns, products intended to be used for the prevention or treatment of serious and/or life-threatening diseases and conditions, as well as products for vulnerable populations and others.
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:
For reporting adverse drug events in animals, please see How to Report Animal Drug Side Effects and Product Problems.