FDA, Health Canada issue pet product alert for King Bio due to microbial contamination

August 29, 2018

[1]The Food and Drug Administration and Health Canada are warning pet owners not to use products, including those labeled as homeopathic drug products, made by King Bio Inc. in Asheville, N.C., and labeled as Dr. King’s, due to high levels of microbial contamination identified at the manufacturing site.

King Bio has expanded a voluntary recall[2] to include all water-based drug products marketed for animals. The FDA and Health Canada recommend consumers stop using and dispose of these products immediately.

King Bio manufactures pet products for urinary incontinence and digestion relief. The full list of products is listed on the King Bio website[3].

Pets who use these products could have an increased risk of serious infection that could require veterinary attention due to high levels of microbial contamination, according to the FDA. Pet owners who have purchased these products should contact their veterinarian if they have concerns or observe signs of an infection after use of these products.

According to King Bio, after a recent FDA inspection, several microbial contaminants were found in its products, including Burkholderia multivorans, which is a strain of bacteria called Burkholderia cepacia complex[4] that can cause illness in those 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.

Health Canada says it is monitoring the company’s recall and any necessary corrective and preventive actions. In Canada, the products are being recalled by the Canadian distributor, Ecotrend Ecologics Ltd. Anyone with questions about can reach the company by phone at (855) 215-2290 or by email at qa@ecotrend.ca[5].

The FDA encourages veterinarians to report adverse events or quality problems experienced with the use of King Bio’s products at How to Report Animal Drug Side Effects and Product Problems[6]. In Canada, report adverse events to Health Canada at (866) 234-2345 or online, by mail, or by fax here[7].

  1. [Image]: https://www.veterinarypracticenews.com/wp-content/uploads/2018/08/King-Bio-Dr.-King.jpg
  2. expanded a voluntary recall: https://www.fda.gov/Safety/Recalls/ucm618585.htm
  3. website: https://www.drkings.com/en/message-from-dr-king/
  4. Burkholderia cepacia complex: https://www.cdc.gov/hai/organisms/bcepacia.html
  5. qa@ecotrend.ca: http://qa@ecotrend.ca
  6. How to Report Animal Drug Side Effects and Product Problems: https://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm055305.htm
  7. here: https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html
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