FDA warns against King Bio products after company expands recall
pharmafile | August 29, 2018 | News story | Research and Development | Contamination, FDA, homeopathy, king bio, recall
The US Food and Drug Administration is warning consumers and pet owners not to use products that have been manufactured by the homeopathic medicine specialist King Bio after high levels of microbial contamination were found at the company’s manufacturing site in Asheville, North Carolina.
The news comes after the company launched a voluntary nationwide recall on three of its products in July. The company later expanded the recall twice having launched a recall of all of its aqueous-based products for human and animal use yesterday. However the FDA has recommended that all customers immediately stop using and dispose of King Bio products after several microbial contaminants were found at the company’s Asheville plant.
FDA Commissioner Dr Scott Gottlieb commented: “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.”
The FDA found that King Bio products were contaminated with several microbial contaminants including Burkholderia Multivorans that can cause illness in people with compromised immune systems. Evidence collected by the FDA also indicates that the water system used by King Bio may have led to recurring microbial contamination.
Dr Gottlieb added that: “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.”
Louis Goss
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