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.
King Bio manufactures a range of products for adults, children and pets. A list of all recalled products can be found on the King Bio website. A list of the recalled pet products is below:
|Product Number||Brand||Product Name||Lot #||UPC Code|
|30-6043||VET||(D) Allergies||032116D & 082216C||357955604341|
|30-6045||VET||(D) Urinary Incontinence||041416D & 102116B||357955604549|
|30-6052||VET||(D) Urinary Tract Irritations||081315E, 081015M, 041416C & 081016A||357955605249|
|30-6118||VET||(D) Trauma & Wounds||081815P & 060716C||357955611844|
|30-6130||VET||(D) Odor Freee||062615F & 081315G||357955613046|
|30-6156||VET||Appetite Control||111516Q & 120616D||357955615644|
|30-6158||VET||(D) Digestion Reliever||081015P & 111516F||357955615842|
|30-6162||VET||(D) Muscle, Joint & Arthritis||081315J, 041416G & 090816E||357955616245|
|30-6168||VET||(D) Skin Irritations & Itch Re||072516K & 011617A||357955616849|
|30-6169||VET||(D) Better Breath/Teeth & Gums||030916X & 090116B||357955616948|
|30-6170||VET||Skin Irritations & Itch Rel(NP||010818D||357955616849|
|30-6171||VET||Better Breath/Teeth & Gums(NP)||121417G||357955616948|
|30-6602||VET||(D) Doggie Drool||081015R||357955660248|
|30-6603||VET||Foul Gas & Stool Relief||112116A||357955660347|
|30-6604||VET||(D) Stop Bark||052516D||357955660446|
|30-6850||VET||Multi Stress Control||081315P & 011217A||357955685043|
|4301C||NATURAL PET||(D) (Cat) Skin & Itch||030816G, 052516A, 062816J, 091416B & 123016C||357955430148|
|4302C||NATURAL PET||(D) (Cat) UTI||082015B, 102215J, 030816F, 072216E, 090816C, 101016C & 010517D||357955430247|
|4304C||NATURAL PET||Anxiety/Stress (Cat)||030816H, 072916B, 101816A & 011817C||357955430445|
|4306C||NATURAL PET||Skin & Itch (Cat) (NP)||121417H||357955430148|
|4307C||NATURAL PET||UTI (Cat) (NP)||090717B, 111617A & 010118BF||357955430247|
|4308C||NATURAL PET||Oral Health (Cat) (NP)||022318E||357955431046|
|4309C||NATURAL PET||Anxiety & Stress (Cat) (NP)||112317B||357955430445|
|4401D||NATURAL PET||(D) (Dog) Allergies||081715A, 033016M, 052516B, 071116K, 090816G & 101016B||357955440147|
|4402D||NATURAL PET||(D) (Dog) Skin & Itch||081315H, 011916B, 033016L, 051116B, 062016C, 071116M, 081016D, 101016D & 101016D||357955440246|
|4403D||NATURAL PET||(D) (Dog) Digestive Upsets||040616AA, 071116L & 020317C||357955440345|
|4404D||NATURAL PET||(D) (Dog) Muscle,Joint & Arthr||082015C, 051116A, 062816H, 071116N, 081216A & 011617E||357955440444|
|4405D||NATURAL PET||Appetite & Weight (Dog)||033016N, 071116J & 042717B||357955440543|
|4406D||NATURAL PET||Teeth & Gums (Dog)||102215K, 041316A, 052516AC & 083116A||357955440642|
|4407D||NATURAL PET||(D) (Dog) Anxiety & Stress||081715B, 051716Q, 072916C & 100716A||357955440741|
|4408D||NATURAL PET||(D) (Dog) Yeast Control||030916L & 020317D||357955440840|
|4409D||NATURAL PET||Allergies (Dog) (NP)||120217S & 041518B||357955440147|
|4410D||NATURAL PET||Skin & Itch (Dog) (NP)||020118E||357955440246|
|4411D||NATURAL PET||Digestive Upsets (Dog) (NP)||011918D||357955440345|
|4412D||NATURAL PET||Muscle,Joint&Arth. (Dog) (NP)||010418A||357955440444|
|4414D||NATURAL PET||Oral Health (Dog) (NP)||102717D||357955442042|
|4415D||NATURAL PET||Anxiety & Stress (Dog) (NP)||092617D||357955440741|
|4416D||NATURAL PET||Yeast Control (Dog) (NP)||110317F||357955440840|
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.
In July 2018, King Bio voluntarily recalled three human drug products labeled as homeopathic due to confirmed microbial contamination. On August 22, 2018, the company then expanded its voluntary recall to include an additional 32 drug products. Then on August 23, 2018, the FDA contacted King Bio 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, which the company did.
To date, no illnesses have been reported as a result of this recall. For reporting adverse drug events in animals to the FDA, please see How to Report Animal Drug Side Effects and Product Problems.
Click here to read the full FDA alert.