King Bio has issued a voluntary recall of 32 of its children’s medicines due to a potential microbial contamination. Use of the contaminated drugs may cause increased infections.
On Aug. 22, the Food and Drug Administration announced that company King Bio has issued a voluntary nationwide recall of 32 of its children’s medications. Evidently, a small number of the products manufactured between August 2017 and April 2018 tested positive for microbial contamination. If the contaminated medications are administered, they may cause infections that may require medical attention or may even cause life-threatening infections in some.
So far, King Bio has not received any reports of illnesses or adverse reactions as a result of taking the medications, but the nationwide recall was conducted “out of an abundance of caution.”
The complete list and lot numbers of the recalled products are posted in the FDA’s announcement regarding the recall. Chicken Pox Symptom Reliever, Children’s Appetite Enhance, DK Newborn Tonic, DK Colic Relief, Children’s Ear Relief Formula, Kids Stress & Anxiety, and Kids Bed Wetting (NP) are just some of the products affected.
Consumers or distributors with the affected products must discontinue use or distribution, and contact King Bio to arrange for the return or replacement of the product.
King Bio is a North Carolina-based company that is known for creating homeopathic medications from newborn tonics to appetite enhancers and sleep aids for kids. In light of the ongoing recall, FDA Commissioner Scott Gottlieb, M.D. tweeted to remind the public that homeopathic drugs are still not proven to be safe or effective.
The law states that homeopathic drugs also fall under the same laws as other drug products, in that they also have to meet the same requirements in regard to misbranding, approval, and adulteration. However, homeopathic drugs have been distributed in the United States since 1988 and have grown into a multimillion dollar industry since. Along with the industry’s massive growth also grew the safety concerns regarding products labeled as homeopathic.
Just last December 2017, the FDA released new risk-based enforcement approach to homeopathic drugs that may prove risky for patients. In it, the FDA’s proposed approach focuses on the homeopathic products that have the highest risk of causing adverse reactions. Such products include those with reported safety concerns, those with ingredients with significant safety concerns, those with administration routes apart from oral and topical, those that claim to prevent life-threatening diseases, and those that do not meet the standards as required by the law.
“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 Gottlieb.