King Bio has issued a recall for dozens of infant and child homeopathic products due to potential microbial contamination that poses a risk of illness that may be life-threatening for some children. Consumers who have these products at home should immediately discontinue use.
At the time of the recall, no illnesses had been reported. Consumers who have noted any adverse reactions to these products in their children should contact their healthcare providers. They can also report these issues to the U.S. Food and Drug Administration’s (FDA’s) MedWatch Adverse Event Reporting program.
The recalled items, many of which were sold in 2 oz spray bottles under the brand name Dr. King’s, were marketed as remedies for ear problems, colic, cough, fever teething, appetite control, bed wetting, and other issues.
Homeopathic Products are not FDA-Approved
Originating in the 1700s, homeopathy is an alternative medical practice based on the notion that substances that cause symptoms can be effective cures for those symptoms if they are diluted. Although there have been several studies that debunk this theory, the market for these products has grown into a $3 billion industry. This, despite the fact that no product labeled “homeopathic” is FDA-approved.
“There are no FDA-approved products labeled as homeopathic; this means that any product labeled as homeopathic is being marketed in the U.S. without FDA evaluation for safety or effectiveness,” according to the FDA’s website.
Since 1988, the agency has allowed these products to manufactured and sold without pre-market approval. “Our approach to regulating homeopathic drugs must evolve to reflect the current complexity of the market, by taking a more risk-based approach to enforcement. We respect that some individuals want to use alternative treatments, but the FDA has a responsibility to protect the public from products that may not deliver any benefit and have the potential to cause harm,” said FDA Commissioner Scott Gottlieb, M.D. when announcing a new risk-based enforcement approach in December 2017.
Products labeled as homeopathic can contain a wide range of substances including some that are harmful to humans. In 2016, the FDA issued a warning about homeopathic teething tablets after seizures and deaths were reported.
Lawsuits for Defective Infant and Child Products
Eric Hageman is our lead attorney with Pritzker Hageman’s Child Safety Litigation Team. Eric is a parent himself and has seen the tragic impact some of these dangerous products can have on a family. If you would like to speak with Eric about your case call 1-877-377-8900 (toll-free) or fill out this free consultation form. The consultation is free and there is no obligation.