Important Information Regarding the Voluntary Recall of the Children's Product: Hyland's Teething Tablets

Information Update
2010-183
October 27, 2010
For immediate release

OTTAWA - Hyland's Homeopathic Canada (Hyland's), a division of Standard Homeopathic Company, in consultation with Health Canada, is voluntarily recalling its Hyland's Teething Tablets from the Canadian market because they may pose a risk to children, according to U.S. Food and Drug Administration (FDA) testing. This recall has been initiated in both Canada and the U.S. as a precautionary measure due to the FDA's ongoing inspection of Standard Homeopathic Company's manufacturing facility in the U.S. Hyland's Teething Tablets are manufactured in the U.S. and distributed throughout North America, including Canada.

Hyland's Teething Tablets are manufactured to contain a small amount of belladonna, a substance that can cause serious harm at larger doses. For such a product, it is important that the amount of belladonna be carefully controlled.

The FDA has received reports of serious adverse events in children taking this product that are consistent with belladonna toxicity but conclusive links have not been formally determined. Please visit the  FDA website for more information.

As of today, Health Canada has not received any adverse reactions regarding Hyland's Teething Tablets.

Hyland's Teething Tablets are sold in pharmacies, retail stores, and on the Internet as an over-the-counter (OTC) homeopathic drug intended to provide temporary relief of symptoms related to teething in children. Canadians who have concerns about these products should consult with their health care practitioners.

Canadians can be confident that Health Canada will be working with Hyland's Homeopathic Canada and the FDA to review their corrective actions taken at the U.S. plant where these products were manufactured.

For more information on Hyland's Homeopathic Canada recall, Canadians can call 1.800.363.8933 or visit  www.hylandsteething.com/recall. Should new information become available, Health Canada will advise Canadians and Canadian health care professionals as soon as it is available.

CANADIAN PRODUCT RECALL INFORMATION

1. Hyland's Teething Tablets, 125 tablets, DIN 01956485 (as per product label)

Health Canada will continue monitoring the safety of health products on the Canadian market manufactured at Standard Homeopathic Company's facility and will inform Canadians if new safety information arises. Canadians can be confident that should any risks to health be identified, Health Canada will take immediate and appropriate action to help protect the health and safety of Canadians.

You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

• Report online at the MedEffect™ Canada section of the Health Canada website
• Call toll-free at 1-866-234-2345
• Complete a Canada Vigilance Reporting Form and either:
  • Fax toll-free to 1-866-678-6789
  • Mail to: Canada Vigilance Program
    • Health Canada
    • AL 0701D
    • Ottawa, ON K1A 0K9

To have postage pre-paid, download the postage paid label from the MedEffect™ Canada section of the Health Canada website. The Canada Vigilance Reporting Form and the adverse reaction reporting guidelines may also be obtained via this section.

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