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King Bio FDA Recall

August 28, 2018
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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.

A Range Of Products Including Those for Children & Pets

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.

Drug Supplement Recall

Products Cause an Increased Risk of Serious Infection

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 healthcare professional if they have concerns or observe signs of an infection after the use of these products.

King Bio Issues Voluntary Recall On All Products Using Water As An Ingredient

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.

FDA and Federal Trade Commission Issue a Joint Warning

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.

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