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

Starting date:

October 27, 2010

Posting date:

October 27, 2010

Type of communication:

Information Update

Subcategory:

Affects children, pregnant or breast feeding women

Source of recall:

Health Canada

Issue:

Product Safety, Non-medicinal Ingredient, Dosage

Audience:

General Public

Identification number:

RA-110003871

• 
  Reason
• 
  What you should do
• 
  Depth of distribution
• 
  Background
• 
  Affected products
• 
  Report health or safety concerns
• 
  Media enquiries
• 
  Public enquiries
• 
  What Health Canada is doing

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.

Reason

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.

What you should do

Canadians who have concerns about these products should consult with their health care practitioners.

For more information on Hyland's Homeopathic Canada recall, Canadians can call 1-800-363-8933.

Depth of distribution

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.

Background

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.

Affected products

Report health or safety concerns

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.

Media enquiries

Health Canada

613-957-2983

Public enquiries

613-957-2991

1-866-225-0709

What Health Canada is doing

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.

Should new information become available, Health Canada will advise Canadians and Canadian health care professionals as soon as it is available.

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.