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Foreign Product Alert: ABC Dophilus® Powder, Feng Shi Ling, Bee Slim, Bee Thin, MR ZACK POWERBRO, Nutri Drops Grapefruit Diet, Super Extreme Accelerator, Slim-Vie, Black Storm, MAGIC PENIS, Max Hard, Rock Hard, SPARTA X

Starting date:
March 9, 2015
Posting date:
March 9, 2015
Type of communication:
Foreign Product Alert (FPA)
Subcategory:
Natural health products
Source of recall:
Health Canada
Issue:
Undeclared Substance, Unauthorized products, Microbial Hazard
Audience:
General Public
Identification number:
RA-52501

Issue

These foreign health products have been found by regulators in other countries to contain undeclared drug ingredients, or unacceptable levels of microbial contamination.

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.

Affected Products
Product Name(s) Hazard(s) Identified Source of Alert Other product information, if available Images
Unauthorized Products (Unknown type)
ABC Dophilus Powder
  • Undeclared fungus (Rhizopus oryzae)
United States Food and Drug Administration Solgar INC. voluntary Recall ABC Dophilus Powder
Unauthorized Pain Relief Products
Feng Shi Ling
  • Undeclared diclofenac
  • Undeclared indomethacin
United States Food and Drug Administration Capsules; Manufactured by Hong Kong Chi Chun Tang Herbal Factory Feng Shi Ling
Unauthorized Weight Loss Products
Bee Slim
  • Undeclared sibutramine
United States Food and Drug Administration Capsules Bee Slim
Bee Thin
  • Undeclared sibutramine
United States Food and Drug Administration   Bee Thin
MR ZACK POWERBRO
  • Undeclared propoxyphenyl hydroxyhomosildenafil
  • Undeclared propoxyphenyl aildenafil
  • Undeclared propoxyphenyl thiohydroxyhomosildenafil
  • Undeclared propoxyphenyl thioaildenafil
Singapore Health Sciences Authority Capsules MR ZACK POWERBRO
MR ZACK POWERBRO-b
Nutri Drops Grapefruit Diet
  • Undeclared sibutramine
  • Undeclared benzyl sibutramine
  • Undeclared phenolphthalein
Singapore Health Sciences Authority Capsules Nutri Drops Grapefruit Diet
Super Extreme Accelerator
  • Undeclared sibutramine
United States Food and Drug Administration   Super Extreme Accelerator
Slim-Vie
  • Undeclared sibutramine
United States Food and Drug Administration Capsules Slim-Vie
Slim-Vie-b
Unauthorized Sexual Enhancement Products
Black Storm
  • Undeclared sildenafil
United States Food and Drug Administration Capsules Black Storm
MAGIC PENIS
  • Undeclared sildenafil
Singapore Health Sciences Authority Capsules MAGIC PENIS
MAGIC PENIS-b
Max Hard
  • Undeclared sildenafil
  • Undeclared aminotadalafil
Australian Therapeutic Goods Administration Capsules Max Hard
Rock Hard
  • Undeclared tadalafil
Australian Therapeutic Goods Administration Tablets Rock Hard
SPARTA X
  • Undeclared hydroxyhomosildenafil
  • Undeclared hydroxythiohomosildenafil
Singapore Health Sciences Authority Capsules SPARTA X
SPARTA X-b

What you should do

  • Contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 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.

Aminotadalafil is an unauthorized substance similar to tadalafil and may pose similar health risks. Tadalafil is a prescription drug used to treat erectile dysfunction. 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.

Benzyl sibutramine is an unauthorized substance similar to sibutramine and may pose similar health risks. 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.

Diclofenac is a prescription drug in the family known as non-steroidal anti-inflammatory drugs (NSAIDs) and is used to treat pain, fever and inflammation. Side effects include changes in blood pressure, gastrointestinal disorders (with or without bleeding), anemia, kidney failure, and reduced blood clotting ability.

Hydroxyhomosildenafil is an unauthorized substance similar to sildenafil and may post similar health risks. Sildenafil is a prescription drug used to treat erectile dysfunction. Sildenafil 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.

Hydroxythiohomosildenafil is an unauthorized substance similar to sildenafil and may post similar health risks. Sildenafil is a prescription drug used to treat erectile dysfunction. Sildenafil 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.

Indomethacin is a prescription drug in the family known as non-steroidal anti-inflammatory drugs (NSAIDs) and is used to treat pain, fever and inflammation. Side effects include changes in blood pressure, gastrointestinal disorders (with or without bleeding), anemia, kidney failure, and reduced blood clotting ability.

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

Propoxyphenyl aildenafil is an unauthorized substance similar to sildenafil and may pose similar health risks. Sildenafil is a prescription drug used to treat erectile dysfunction. Sildenafil 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.

Propoxyphenyl hydroxyhomosildenafil is an unauthorized substance similar to sildenafil and may pose similar health risks. Sildenafil is a prescription drug used to treat erectile dysfunction. Sildenafil 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.

Propoxyphenyl thioaildenafil is an unauthorized substance similar to sildenafil and may pose similar health risks. Sildenafil is a prescription drug used to treat erectile dysfunction. Sildenafil 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.

Propoxyphenyl thiohydroxyhomosildenafil is an unauthorized substance similar to sildenafil and may pose similar health risks. Sildenafil is a prescription drug used to treat erectile dysfunction. Sildenafil 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.

Rhizopus oryzae is a fungus that can cause severe infection. Individuals with weakened immune systems such as premature infants, patients with diabetes, cancer and extensive burns are at increased risk of developing this infection. Infected individuals may experience fever, headache, eye swelling, bloody nasal discharge, fast breathing, cough, abdominal pain and/or bloody diarrhea.

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.

Sildenafil is a prescription drug used to treat erectile dysfunction. Sildenafil 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.

Tadalafil is a prescription drug used to treat erectile dysfunction. 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 February 13, 2015, no adverse reactions suspected to be associated with the use of these products have been reported to Health Canada.

Images

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