The FDA has issued a safety notice regarding a product that we’ve used lots of times – and which I’m sure many of you have too.
Yesterday’s FDA news release states that Hyland’s Teething Tablets may pose a risk to children.
The reason given is that these homeopathic tablets are manufactured to contain a small quantity of belladonna. At larger doses, belladonna can cause serious harm – so it is important that the amount of belladonna in products is carefully controlled. According to the FDA’s notice, Hyland’s Teething Tablets contain inconsistent amounts of belladonna – furthermore, the FDA says it has received reports of children suffering serious adverse effects “consistent with belladonna toxicity”. The FDA recall notice states that “an ongoing inspection at the manufacturer also indicates substandard control of the manufacturing operation”.
There have also been reports of children taking more than the recommended amount of these tablets because the containers do not have child resistant caps.
If you have used these tablets and your child is experiencing symptoms such as seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, you are advised to contact a healthcare professional.
If you have any of these tablets at home, you are advised NOT to use them and to dispose of them. The recall notice on the Hyland’s website states that you can request a refund or replacement by contacting Standard Homeopathic Company on 1-877-496-5044 (Monday-Friday 8 a.m. to 10 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time) or by logging on to www.hylandsteething.com/recall. The company can also offer advice as to how to safely dispose of the tablets.
If your child has experienced any adverse effects after using Hyland’s tablets, the FDA requests that you report them to the FDA’s MedWatch Adverse Event Reporting program by either:
Completing and submitting the report online: www.fda.gov/MedWatch/report.htm
Downloading a form or calling 1-800-332-1088 to request a reporting form, then completing and returning to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Recall of Hyland's Teething Tablets in Canada | The Homemade Baby Food Recipes Blog
Thursday 28th of October 2010
[...] days ago we wrote a post about the recall of Hyland’s Teething Tablets in the United States. These tablets have now been recalled in Canada for the same reason, although the recall notice [...]