Following an investigation of its manufacturing facility by the U.S. Food and Drug Administration (FDA), Standard Homeopathic Co. announced that it is voluntarily pulling its popular Hyland’s Teething Tablets from all retail shelves. Although Standard Homeopathic maintains that the products are safe, the 107-year-old company said it is initiating the recall “in an abundance of caution” after the FDA identified problems in the manufacture of its Teething Tablets.
In a warning issued October 23, the FDA advised consumers not to use Hyland’s Teething Tablets and dispose of any of the product in their possession. Hyland’s Teething Tablets contain a small amount of belladonna, which can cause serious harm at larger doses. The FDA reported it had found inconsistent amounts of belladonna in the product during a laboratory analysis. The agency also said it had received reports of serious adverse events in children taking Hyland’s Teething Tablets “that are consistent with belladonna toxicity.” Hyland’s Teething Tablets is an over-the-counter homeopathic product intended to provide temporary relief of teething symptoms in infants and children.
In a statement, Standard Homeopathic said its own in-depth analysis, a comprehensive review of the company’s adverse event report log and more than 85 years of safe usage make it confident that Hyland’s Teething Tablets are safe for babies and kids. “We initiated this voluntary recall to ensure our consumers know that their families’ safety and health are our top priorities,” said Mark Phillips, PharmD, president and chief pharmacist of Standard Homeopathic Co. “We are committed to maintaining and deserving the trust they have placed in Hyland’s. We have worked for 107 years to build relationships with our consumers. We intend to preserve that tradition of trust.”
Wednesday, October 27, 2010
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