According to CNN, the company said it has not agreed to the recall because it discontinued the sale of this product in the United States on October 7. And there is no proven health benefit of the products, which are labeled to relieve teething symptoms in children.
Homeopathic teething tablets have been around since the 1900s.
The FDA also would like consumers and health care professionals to submit reports of the adverse effects at the FDA's MedWatch Adverse Event Reporting program.
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The National Center for Homeopathy, which has ties with Hyland's, slammed the FDA, calling the agency's warnings "arbitrary and capricious". Around the same time, the Federal Trade Commission announced that it will begin requiring makers of homeopathic products to add warnings in advertisements and on packaging that state that: 1) there is no scientific evidence that they are effective, and 2) any claims of effectiveness are only based on homeopathic theories, which are not accepted by science.
Hyland's temporarily took the tablets off the market, but has since re-released the product after changing their manufacturing process to ensure consistent levels of belladonna. Families are the core of what we do.
Instead of teething gels or tablets, the American Academy of Pediatrics recommends gently rubbing or massaging the child's gums with your finger and giving the child a cool (not cold) teething ring or a clean, wet, cool washcloth to chew on.
"We discontinued it because we are committed to our moms and our dads who choose to trust us to put medicines in their young infants' mouths, and we didn't want to put them in a place between the FDA warning and us saying the product was safe and having to decide who to trust", said Mary C. Borneman, a spokeswoman for Hyland's, in a CNN report. However, in the past, companies like Raritan Pharmaceuticals have recalled several of their teething products due to the levels of belladonna.