TUESDAY, Aug. 28, 2018 -- Hundreds of Dr. King's water-based homeopathic drugs for children, adults and pets may be unsafe to use because of high levels of microbial contamination, the U.S. Food and Drug Administration said Tuesday.
Due to the risk of infection, consumers with these products made by King Bio Inc. of Asheville, N.C., should throw them away, the agency stressed.
Products covered by the recall include: Dr. King's Children's Cough Relief; Dr. King's Chicken Pox Symptom Relief; Dr. King's Children's Ear Relief Formula; Dr. King's Children's Appetite Enhancer; Dr. King's Attention and Learning Enhancement for Kids; Dr. King's Cold Sore treatment; Dr. King's Wart Freeze; and pet products for urinary incontinence and digestion relief.
A full list is available on the King Bio website.
Those at highest risk from the recalled products include infants, children, pregnant women and people with weakened immune systems, the FDA said.
In July, King Bio voluntarily recalled three homeopathic drug products due to confirmed microbial contamination, and on Aug. 22 it expanded that recall to include 32 more products. On Aug. 23, the FDA advised the company to recall all of its water-based drug products.
The FDA recently inspected King Bio's facility and collected product samples, and the agency is testing and analyzing those samples.
"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," FDA Commissioner Dr. Scott Gottlieb said in an agency news release.
Early this year, the FDA and Federal Trade Commission issued a joint warning letter to King Bio for illegally marketing an unapproved product to prevent, cure or treat opioid addiction, the federal officials 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. In addition to our concerns with contamination, some homeopathic products may not deliver any benefit and have the potential to cause harm," Gottlieb said.
More information
Here's where you can find the complete list of the recalled Dr. King's products.
(https://www.drugs.com/)
Due to the risk of infection, consumers with these products made by King Bio Inc. of Asheville, N.C., should throw them away, the agency stressed.
Products covered by the recall include: Dr. King's Children's Cough Relief; Dr. King's Chicken Pox Symptom Relief; Dr. King's Children's Ear Relief Formula; Dr. King's Children's Appetite Enhancer; Dr. King's Attention and Learning Enhancement for Kids; Dr. King's Cold Sore treatment; Dr. King's Wart Freeze; and pet products for urinary incontinence and digestion relief.
A full list is available on the King Bio website.
Those at highest risk from the recalled products include infants, children, pregnant women and people with weakened immune systems, the FDA said.
In July, King Bio voluntarily recalled three homeopathic drug products due to confirmed microbial contamination, and on Aug. 22 it expanded that recall to include 32 more products. On Aug. 23, the FDA advised the company to recall all of its water-based drug products.
The FDA recently inspected King Bio's facility and collected product samples, and the agency is testing and analyzing those samples.
"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," FDA Commissioner Dr. Scott Gottlieb said in an agency news release.
Early this year, the FDA and Federal Trade Commission issued a joint warning letter to King Bio for illegally marketing an unapproved product to prevent, cure or treat opioid addiction, the federal officials 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. In addition to our concerns with contamination, some homeopathic products may not deliver any benefit and have the potential to cause harm," Gottlieb said.
More information
Here's where you can find the complete list of the recalled Dr. King's products.
(https://www.drugs.com/)
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