The homeopathic manufacturer King Bio has now launched a recall to record all of its water-based treatments for humans and animals – an extensive list of nearly 600 products. The expansion comes when the Food and Drug Administration (FDA) announced "high levels of microbial contamination" that appear to be recurring and cause "life-threatening" infections.
The recall extension is the second for King Bio. For the first time, a recall of just three products was announced in July. Last week, the company voluntarily extended the recall to 32 infant and infant products.
But the FDA was not satisfied. On Tuesday, the agency issued its own warning about King Bio's products, offering a devastating perspective on the company's production standards and business.
The agency's warning cited FDA Commissioner Scott Gottlieb:
We take product quality issues seriously, and when we find below-average conditions in our inspections ̵1; in this case, conditions leading to high microbial contamination with the potential cause damage to the public – we act quickly to make sure that the products are removed
The alert went on to note that in a recent FDA inspection of King Bio's manufacturing facility, the agency discovered that "several" microbial contaminants had appeared in the company's products, including bacteria Burkholderia multivorans . This is an opportunistic agent that causes serious illnesses in people with weakened immune systems and is a rare but emerging cause of meningitis. The FDA added that it also found evidence of "recurrent microbial contamination associated with the water system used to make medicines".
After King Bio released the extended recall on August 22, the FDA promptly informed the company more. "The FDA contacted King Bio on August 23, 2018 and recommended that the company extend its recall to all products that use water as an ingredient, including human and animal drugs," the agency said in the bid.
King Bio has done so, recalling an exhaustive list of nearly 600 water-based products for adults, children, infants and pets. The products are sold under the brand name Dr. Ing. King's: Natural Medicine, Aquaflora, Natural Pet Pharmaceuticals, SafeCareRx, Natural Veterinary and Safecare. Consumers can see the complete lists here and here.
King Bio's founder and president, Naturopath Frank King, the "Dr. King," posted on the company's website a statement on the expansion and stated:
Although there are no reports of illness or injury due to one of our products, we decided to give the recall out of a lot of caution. We truly regret the inconvenience or concern that our recall may have caused, but we considered this the right decision to maintain your confidence.
In an email to Ars, a representative of King Bio declined to comment further, including requests for a comment on the FDA's concerns over manufacturing conditions or what the company is doing to correct the contamination problem
Meanwhile, FDA seems to be making something of an example for King Bio. Last December, the agency said it would crack down on homoeopathic products makers, and action against King Bio appears to be part of that effort.
Dr. Gottlieb went on to say in warning:
In recent years, we have seen a great increase in homeopathic products marketed for a wide range of diseases and conditions, from the common cold to cancer. In addition to our concerns about contamination, some homeopathic products may not be beneficial and potentially harmful. For this reason, we took steps last year to advance a new regulatory approach to prioritize additional enforcement and regulatory measures against certain homeopathic products. We focus on products that pose the greatest risk to patients, including products for vulnerable populations such as children. Last year, we also took action against homeopathic products claiming unproven drug claims.