King Bio manufactures a range of products including those for children, adults and pets. Pet products were specifically manufactured for urinary incontinence and digestion relief.
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.
Consumers and pets that 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.
For reporting adverse drug events in animals, please see How to Report Animal Drug Side Effects and Product Problems.
Consumers, distributors, and retailers that have recalled product should discontinue use and or distribution and contact King Bio at: email@example.com to arrange a return.
Consumers with questions regarding this recall can contact King Bio at 866-298-2740 or e-mail firstname.lastname@example.org, Monday – Thursday 8:30 a.m. – 3:30 p.m., EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products.
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