Hundreds of King Bio Homeopathic Products Recalled Due to Risk of Bacterial Contamination
The U.S. Food and Drug Administration (FDA) is warning consumers not to use drug products made by King Bio Inc., a company that makes homeopathic drugs for both people and pets.
The products may pose health risks due to bacterial contamination, the FDA said in a statement. Such contamination could lead to serious infection, particularly for infants, children, pregnant women and people with weakened immune systems, the FDA said.
Recently, some of the products were found to be contaminated with various bacteria, including the bacterium Burkholderia multivorans, which can cause illness in people with weakened immune systems.
And during an FDA inspection of the company's manufacturing facility, the agency found evidence of "recurring microbial contamination" tied to the water system used to manufacture the drug products.
As such, the FDA recommended that King Bio recall all of its products that use water as an ingredient. On Aug. 27, the company complied, and recalled hundreds of its water-based products. This step expanded an earlier recall that included only 32 products.
King Bio said that, so far, the company has not received any reports of injury or illness tied to its products.
The FDA noted that homeopathic products in general pose concerns, not just because of possible bacterial contamination but also because of the way they are marketed. The products are often marketed as "natural," "safe" and "effective," but the FDA has not approved any homeopathic products for specific treatments, meaning that the products have not been evaluated for safety and effectiveness, the agency said.
"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," FDA Commissioner Dr. Scott Gottlieb said in the FDA's statement. "In addition to our concerns with contamination, some homeopathic products may not deliver any benefit and have the potential to cause harm."
In January, the FDA sent a warning letter to King Bio because the company was illegally marketing an unapproved product to prevent, cure or treat opioid addiction, the agency said.
Original article on Live Science.
