"These products may pose a safety risk to people (especially infants, children, pregnant women and those with compromised immune systems), as well as pets due to high levels of microbial contamination identified at the manufacturing site," the agency said.
The warning was issued as the company expanded a recall of these products, which are labeled as Dr. King's. They include symptom relievers for ear infections, coughs, chicken pox, cold sores, warts, styes, swollen glands, snoring and tremors, appetite enhancers, attention and learning enhancers, and body detox. Also included are pet products for urinary incontinence, anxiety, allergies, muscle and joint arthritis, and digestion relief.
A list of the hundreds of products is posted online
with a message from company founder Franklin King.
"While there have been no reports of illness or injury due to any of our products, we chose to issue the recall out of an abundance of caution," the message says.
According to the FDA, King Bio said "several microbial contaminants were found in its products, including Burkholderia Multivorans, which is a strain of bacteria called Burkholderia cepacia complex (BCC) that can cause illness in people 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."
The agency said samples collected during a recent FDA inspection are being tested and analyzed.
Initially, King Bio recalled
three products July 20 after the company identified microbial contamination. On August 22, the recall was expanded to include 32 products.
This week, the recall was expanded again to include
all aqueous-based, or water-based, products.
All of the products are homeopathic or supplemental and thus are not regulated by the FDA and do not have to follow standards ensuring that they are safe and effective.
"These unapproved drugs may cause significant and even irreparable harm if they are poorly manufactured, which can lead to contamination, or contain active ingredients that aren't adequately tested or disclosed to patients," the FDA said in a statement.
"Products labeled as homeopathic can contain a wide range of substances, including ingredients derived from plants, healthy or diseased animal or human sources, minerals, and chemicals. These products are often marketed as natural, safe and effective alternatives to approved prescription and nonprescription products, and are sold online and in major retail stores."
Anyone who has any of the recalled products should contact the company. These drugs should not be sold or consumed.
Anyone experiencing an adverse event from one of these products should report it to the FDA
This is not the first problem for King Bio this year, according to the FDA, which said that it and the Federal Trade Commission sent the company a warning letter in January for illegal marketing of products to "prevent, cure or treat opioid addiction." The product in question is not approved for this use.