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Recall of Hyland's Teething Tablets - Risk to Children

Hyland's Teething Tablets are being recalled due to higher than normal levels of belladonna, which can cause serious harm. Consumers are advised not to use the product and to consult a healthcare professional if their child experiences any symptoms. Ongoing inspection of the manufacturing facility indicates substandard control.

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Recall of Hyland's Teething Tablets - Risk to Children

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  1. ISE 427 Thomas Knerr Nov. 4, 2010 What: Teething Tablets Used to ease infants teething process When: 10/23/2010 Why: Hyland’s Teething Tablets are being recalled because the tablets may pose a risk to children from inconsistent levels of belladonna, a substance that can cause serious harm at larger doses How: Higher than normal levels of belladonna in tablets Children taking more tablets than needed Hyland’s Teething Tablets: Recall - Risk of Harm to Children

  2. Recall: Oct. 23, 2010 - Present • The company is initiating this recall in an abundance of caution due to an FDA investigation of its manufacturing facility • An ongoing inspection at the manufacturer also indicates substandard control of the manufacturing operation • FDA recommends that consumers not use this product and dispose of any in their possession. • FDA advises consumers to consult their health care professional if their child experiences symptoms such as seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using Hyland’s Teething Tablets. ISE 427 Thomas Knerr Nov. 4, 2010 Management ISSUES

  3. Ongoing inspection of production facility • Total Cost Unknown. Prediction is in the Tens of Millions • “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 Company. “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.” • Potentially could lose their majority of the market share in pediatric medications ISE 427 Thomas Knerr Nov. 4, 2010 Recall Impact

  4. Elias, M. Some Alternative Remedies Can Harm kids. (2005, October 12). USA Today, p.D6. • Columbia University. (2010). Columbia Electronic Encyclopedia (6th ed., Vol 2). New York: Grove • Colombo, M., Assisi, F. Puppa, T. D., Moro, P., Sesana, F., Bissoli, M., Perego, S. (2010). Most common plant exposures and intoxications from outdoor toxic plants. Journal of Pharmaceutical Sciences and Research, Vol. 2, 417-425. • Leff, R., Berstein, S. (1968). Diseases of the Nervous System. Journal of Physiology and Neuroscience,29(9),621-626. • Hyland’s Products. (2010). Press Release: Hyland’s Teething Tablets. Retrieved November 3, 2010, from http://www.hylands.com/news/hylands-teething-recall.php ISE 427 Thomas Knerr Nov. 4, 2010 References

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