Foreign Product Alerts: Pro ArthMax, Adipotrim XT and StemAlive
- Starting date:
- June 17, 2014
- Posting date:
- June 17, 2014
- Type of communication:
- Foreign Product Alert (FPA)
- Subcategory:
- Natural health products
- Source of recall:
- Health Canada
- Source of alert:
-
The United States Food and Drug Administration (FDA)
Undeclared Ingredients - Issue:
- Undeclared Substance
- Audience:
- General Public
- Identification number:
- RA-39939
Introduction
These 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
- Pro ArthMax
- Adipotrim XT
- StemAlive
Pro ArthMax
Product description
This product is promoted for pain relief.
Hazard identified
The U.S. Food and Drug Administration (FDA) warned consumers not to use this product after it was found to have undeclared ingredients. The ingredients of concern were: diclofenac, ibuprofen, naproxen, indomethacin, chlorzoxazone and nefopam.
- Diclofenac, ibuprofen, naproxen and indomethacin are drugs in the family known as non-steroidal anti-inflammatory drugs (NSAIDs) and are used to treat pain, fever and inflammation. Diclofenac and indomethacin should only be taken under the supervision of a healthcare professional.
- Chlorzoxazone is a non-prescription muscle relaxant.
- Nefopam is a prescription drug used to treat pain and is not authorized for sale in Canada.
Place of origin
Distributor: Human Science Foundation
Side effects
- Side effects associated with diclofenac, ibuprofen, naproxen and indomethacin include changes in blood pressure, gastrointestinal disorders (with or without bleeding), anemia, kidney failure and reduced blood clotting ability.
- Chlorzoxazone may cause drowsiness, dizziness and light-headedness. These effects impair a person’s ability to drive safely or operate machinery.
- Side effects associated with nefopam include nausea, dry mouth, seizures, hallucinations, rapid heart rate, tremors and urinary retention.
Adipotrim XT
Product description
This product is promoted for weight loss and is packaged in 30-count plastic bottles. The affected lot number is 052012.
Hazard identified
The U.S. Food and Drug Administration (FDA) warned consumers not to use this product after it was found to contain undeclared fluoxetine.
-
Fluoxetine is a prescription drug used to treat depression. It should only be taken under the supervision of a healthcare professional.
Place of origin
The manufacturer/distributor is Deseo Rebajar Inc.
Side effects
Side effects associated with fluoxetine include headache, sleeping problems, anxiety, nausea, loss of appetite and excessive sweating.
StemAlive
Product description
This product is promoted as a dietary supplement promoting adult stem cell function and health. The product is packaged in a white plastic bottle with a white and gold label. Each bottle contains 90 capsules. The lot number and expiration date is printed in black ink at the bottom of the label. The affected products are the following:
| Lot Number | Expiration Date |
|---|---|
| 8419 | 05/2015, 06/2015 |
| 8486 | 07/2015 |
| 8535 | 08/2015 |
| 8598 | 10/2015 |
| 8652 | 12/2015 |
| 8863 | 01/2016, 02/2016 |
| 8872 | 03/2016 |
| 8873 | 04/2016, 05/2016 |
| 9040 | 08/2016, 09/2016 |
| 9258 | 10/2016 |
| 9314 | 11/2016 |
Hazard identified
The U.S. Food and Drug Administration (FDA) warned consumers not to use this product after it was found to contain undeclared milk.
Place of origin
The manufacturer/distributor is Stemvida International Corporation (Ontario, California).
Side effects
- 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.
What you should do
Health Canada advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find the products listed above in the Canadian marketplace.
Canadians who have these products are advised not to use them, and should consult with a healthcare professional if they have concerns about their health related to the use of these products.
Background
Drugs and natural health products that are authorized for sale in Canada will have an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) on the label. These numbers indicate that the products have been assessed by Health Canada for safety, effectiveness and quality.
As of May 15, 2014, no adverse reactions suspected to be associated with the use of these products have been reported to Health Canada.
Report a health or safety concern
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
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