Foreign Product Alert: DR's Secret Bio Herbs Coffee, Exhilarate, Ultimate Nutrition Amino Gold (1000mg capsules, 1000mg tablets, 1500mg tablets), Michael's® Naturopathic Programs Cholesterol Metabolism Factors

Starting date:
July 28, 2016
Posting date:
July 28, 2016
Type of communication:
Foreign Product Alert (FPA)
Subcategory:
Natural health products
Source of recall:
Health Canada
Issue:
Important Safety Information, Undeclared Substance
Audience:
General Public
Identification number:
RA-59588

Issue

These foreign health products have been found by regulators in other countries to contain undeclared allergens and or undeclared drug ingredients.

The products are not authorized for sale in Canada and have not been found in the Canadian marketplace but it is possible they may have been brought into the country by travellers or purchased over the Internet.

Unauthorized Health Products
Product Name(s) Hazard(s) Identified Source of Alert Other product information, if available Images
Unauthorized Sexual Enhancement Products
DR's Secret Bio Herbs Coffee Undeclared tadalafil United States Food and Drug Administration   DR's Secret Bio Herbs Coffee
Unauthorized Weight Loss Products
Exhilarate Undeclared sibutramine, desmethylsibutramine, phenolphthalein United States Food and Drug Administration   Exhilarate
Unauthorized Dietary Supplements
Ultimate Nutrition Amino Gold Capsules 1000mg Undeclared milk United States Food and Drug Administration   Ultimate Nutrition Amino Gold Capsules 1000mg
Ultimate Nutrition Amino Gold Tablets (1000mg) Undeclared milk United States Food and Drug Administration   Ultimate Nutrition Amino Gold Tablets (1000mg)
Ultimate Nutrition Amino Gold Tablets (1500mg) Undeclared milk United States Food and Drug Administration   Ultimate Nutrition Amino Gold Tablets (1500mg)
Michael's® Naturopathic Programs Cholesterol Metabolism Factors Undeclared milk and soy United States Food and Drug Administration 90 count, 180 count, 270 count

Lot # (best by date):

  • 1307013 (6/2016)
  • 1310060 (10/2016)
  • 1402177 (3/2017)
  • 1405356 (6/2017)
  • 1408114 (8/2017)
  • 1410186 (11/2017)
  • 1501476 (2/2018)
  • 1505367 (6/2018)
  • 1510296 (11/2018)
  • 1602062 (3/2019)
Michael's® Naturopathic Programs Cholesterol Metabolism Factors

 

What you should do

  • Contact Health Canada at 1-800-267-9675 or by completing an online complaint form if you find a product listed above in the Canadian marketplace.
  • Consult with a healthcare professional if you have health concerns related to the use of any of these products.
  • Read the label of the products you buy to verify that they have been assessed by Health Canada for safety, effectiveness and quality. Health products that have been authorized for sale by Health Canada will have an eight-digit Drug Identification Number (DIN), Natural Product Number (NPN) or a Homeopathic Drug Number (DIN-HM).

Background

Prescription drugs should only be used under the supervision of a healthcare professional.

Desmethylsibutramine is an unauthorized substance similar to sibutramine, a prescription drug previously used to treat obesity and may pose similar health risks. Sibutramine is no longer authorized for sale in Canada because of its association with an increased risk of cardiovascular side effects such as heart attack and stroke. Other side effects include increased blood pressure and heart rate, dry mouth, difficulty sleeping and constipation.

Milk can cause allergic reactions in certain individuals. An allergic reaction occurs when the body's immune system reacts to a foreign substance. The reaction can range from mild to life-threatening (i.e. an anaphylactic reaction). A mild reaction includes itchy and/or runny eyes and nose, skin rash and sneezing. A severe reaction includes swelling, difficulty breathing and/or swallowing, dizziness, a sudden drop in blood pressure and loss of consciousness.

Phenolphthalein was previously used as a laxative but is no longer authorized for sale in Canada because it may cause cancer. Additional side effects include decreased blood pressure, skin rash and gastrointestinal bleeding.

Sibutramine was previously used to treat obesity but is no longer authorized for sale in Canada because of its association with an increased risk of cardiovascular side effects such as heart attack and stroke. Other side effects include increased blood pressure and heart rate, dry mouth, difficulty sleeping and constipation.

Soy can cause allergic reactions in certain individuals. An allergic reaction occurs when the body's immune system reacts to a foreign substance. The reaction can range from mild to life-threatening (i.e. an anaphylactic reaction). A mild reaction includes itchy and/or runny eyes and nose, skin rash and sneezing. A severe reaction includes swelling, difficulty breathing and/or swallowing, dizziness, a sudden drop in blood pressure and loss of consciousness.

Tadalafil is a prescription drug used to treat erectile dysfunction. It should only be taken under the supervision of a healthcare professional. Tadalafil should not be used by individuals taking any kind of nitrate drug (e.g., nitroglycerine) as it can cause potentially life-threatening low blood pressure. Individuals with heart problems are at increased risk of cardiovascular side effects such as heart attack, stroke, chest pain, high blood pressure and abnormal heartbeat. Other side effects include headache, facial flushing, indigestion, dizziness, abnormal vision, and hearing loss.

Report health or safety concerns

To report a side effect to a health product to Health Canada:

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

As of July 27, 2016, no adverse reactions suspected to be associated with the use of these products have been reported to Health Canada.

Images

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