Children’s OTC Medicines Recalled for Potential Contamination
The Food and Drug Administration (FDA) recently announced that King Bio—a North Carolina-based producer of homeopathic medications—has issued a voluntary nationwide recall for 32 of the company’s products.
Sources indicate that some products manufactured by King Bio between August 2017 and April 2018 have tested positive for microbial contamination. While no reports of adverse reactions or illnesses have been received, the company advises distributors or consumers of the 32 affected products to discontinue use and arrange returns. Among the listed products are:
- Chicken Pox Symptom Reliever
- Children’s Appetite Enhance
- DK Newborn Tonic
- DK Colic Relief
- Children’s Ear Relief Formula
- Kids Stress & Anxiety
- Kids Bed Wetting (NP)
While the FDA has reminded the public that homeopathic drugs are not proven safe or effective, they are still subject to the same laws as other drug products—including requirements regarding misbranding, approval, and adulteration. In December 2017, the FDA released a new risk-based enforcement approach focused on homeopathic products with a high risk of adverse reactions and significant safety concerns.
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