Unauthorized Panasilver product for children and adults may pose serious health risk

Starting date:
January 24, 2019
Type of communication:
Advisory
Subcategory:
Drugs, Affects children, pregnant or breast feeding women
Source of recall:
Health Canada
Identification number:
RA-68928

Issue

Health Canada is advising Canadians that Panasilver, a product distributed by Activation Products Canada Inc., in Cobourg, Ontario, is not authorized for sale and may pose serious health risks.

Panasilver contains colloidal silver. Consuming products that contain colloidal silver may lead to the accumulation of silver in the body, which can cause a condition called generalized argyria. Generalized argyria is the permanent bluish-gray discolouration of the skin, eyes and nails. Children and pregnant women are particularly at risk. Colloidal silver can cross the placenta and could lead to problems with a developing fetus. Despite a lower dosage indicated for children, children are more susceptible than adults to serious health risks.

Panasilver is labelled for use as a “daily immune system support” for adults and children. This product was sold online and may have been sold at retail stores. At Health Canada’s request, Activation Products Canada Inc. has stopped sales and is recalling the product.

In addition to selling a product not authorized for sale in Canada, Activation Products Canada Inc. was also found to be operating without a Health Canada site or establishment licence, despite informing the Department that they had previously stopped all licensable activities. This is a serious safety concern. A site or establishment licence indicates that a company has processes and procedures in place that meet Health Canada’s requirements to track and recall health products. The licence also indicates that the company is manufacturing, packaging and labelling products in accordance with good manufacturing practices (a standard that helps to ensure the quality of health products sold to Canadians).

Health Canada inspectors seized equipment and products at the site. Health Canada is considering further actions to address this issue and will inform Canadians as needed should any new health risks be identified.

Products affected

Panasilver

What you should do

  • Stop using this product. Consult your health care professional if you have used this product and have health concerns.
  • Read product labels to verify that health products have been authorized for sale by Health Canada. Authorized health products have an eight-digit Drug Identification Number (DIN), Natural Product Number (NPN) or Homeopathic Drug Number (DIN-HM). You can also check whether products have been authorized for sale by searching Health Canada's Drug Product Database and Licensed Natural Health Product Database.
  • Contact Activation Products Canada Inc. toll free at 1-866-271-7595, or by email at support@activationproducts.com, if you have questions about the recall.
  • Report any health product-related adverse reactions or complaints to Health Canada.

Who is affected

Consumers who have bought or used this product.

Media enquiries

Health Canada
(613) 957-2983
hc.media.sc@canada.ca

Public enquiries

(613) 957-2991
1-866 225-0709

What Health Canada is doing

Health Canada has seized products and equipment from Activation Products Canada Inc., located at 74 Willmott Street, Cobourg, Ontario. The Department has requested that the company recall and stop further sales of the product. Should additional safety concerns be identified related to this issue, Health Canada will take appropriate action and inform Canadians as necessary.

Images

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