Pharmacy Services
Hyland's Teething Tablets Recalled - Potential Risk of Harm to Children
October 25, 2010
Standard Homeopathic Company is voluntarily recalling all lots of their homeopathic over-the-counter Hyland’s Teething Tablets because of the potential to harm children. Hyland’s Teething Tablets are intended to provide a small amount of belladonna, but FDA analysis found them to contain inconsistent amounts. FDA inspection of the manufacturing plant found control of the operation to be substandard.
Belladonna (also called Deadly Nightshade) contains anticholinergic plant alkaloids that are potentially harmful. Symptoms of belladonna toxicity may include agitation, skin flushing, constipation, urinary retention, dry skin, dry mouth, tachycardia, hyperthermia, dilated pupils, confusion, drowsiness, hallucinations, seizures, and trouble breathing. FDA has received reports of belladonna toxicity in children, along with reports of children receiving higher-than-recommended doses because the container is not child-resistant.
Educate consumers to immediately discontinue use and dispose of Hyland’s Teething Tablets. Consult a healthcare professional immediately if a child develops symptoms of belladonna toxicity after using these products. Report adverse events related to this product to the MedWatch program.
Additional information is available at the following links:
- MedWatch Alert:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm230764.htm - FDA Press Release:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm230761.htm - FDA Consumer Update – Questions and Answers:
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm230762.htm
Updated
October 25, 2010; University of Utah, Drug Information Service. Copyright 2010, Drug Information Service, University of Utah, Salt Lake City, UT.
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