Heartland Natural Wild Yam Moisturizing Cream contains undisclosed prescription drug ingredient

Starting date:

May 23, 2014

Posting date:

May 23, 2014

Type of communication:

Advisory

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Undeclared Substance

Audience:

General Public

Identification number:

RA-39595

• Issue
• Products affected
• What you should do
• Who is affected
• Background
• Report health or safety concerns
• Media enquiries
• Public enquiries
• What Health Canada is doing
• Images

Issue

Health Canada has requested that Christmas Natural Foods Ltd. stop selling and recall its unauthorized health product, Heartland Natural Wild Yam Moisturizing Cream, after testing conducted by the Department identified a undisclosed prescription drug ingredient, progesterone. Approved drugs that contain progesterone can only be sold by prescription. Progesterone can be associated with serious side effects, including an increased risk of blood clots.

Products affected

1. Heartland Natural Wild Yam Moisturizing Cream

What you should do

• Contact your health care practitioner if you have any questions or concerns regarding the use of this product.
• Call Health Canada's toll-free line at 1-800-267-9675 with questions or complaints about this product.
• Report any adverse events with this product to Health Canada.

Who is affected

Canadians who have used or purchased Heartland Natural Wild Yam Moisturizing Cream.

Background

Progesterone is associated with side effects, in particular in certain vulnerable patients (for example, patients at risk of blood clots). Patients using this cream who are already taking progesterone-containing medications (i.e. birth control pills, hormone replacement therapy) may be at an elevated risk due to their overall progesterone exposure. Health risks most commonly arise after the long-term use of a cream containing undeclared progesterone.

Report health or safety concerns

• Call toll-free at 1-866-234-2345
• Visit MedEffect Canada's web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Media enquiries

Health Canada
(613) 957-2983

Public enquiries

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

What Health Canada is doing

Health Canada will continue to work with the company to help ensure this product is recalled from the Canadian market. Should there be new information, Health Canada will inform Canadians, as necessary.

Images

Select thumbnail to enlarge - opens in a new window