Foreign Product Alerts 2010
Health Canada is advising consumers not to use the products specified below due to concerns about possible side-effects.
These products are not authorized for sale in Canada and have not been found in the Canadian marketplace. However, it is possible these products could be purchased by Canadians travelling abroad or have been brought into Canada through personal importation by travellers or purchased over the Internet.
Canadians who have these products are advised not to use them, and should consult with a health care professional if they have concerns about their health related to the use of these products. More info
December
- Slimming Beauty Bitter Orange Slimming Capsule [2010-12-16]
The U.S. Food and Drug Administration warned consumers not to buy or use this product after lab tests revealed that this product contains undeclared sibutramine, a pharmaceutical substance that is no longer authorized in Canada because of its association with an increased risk of cardiovascular side effects such as heart attack and stroke. The product also contains bitter orange (Citrus aurantium), a source of synephrine, which is not authorized for use in weight loss products in Canada.
- Shaguar, Signature Signergy, VIGRX (green capsule), VIGRX (white capsule), VigRx, VigRX Plus [2010-12-16]
New Zealand's MedSafe warned consumers to not buy or use these products after they were found to contain the undeclared pharmaceutical substances sildenafil, hydroxyhomosildenafil, thiosildenafil, and/or tadalafil. Sildenafil and tadalafil are prescription drugs and should only be taken under the supervision of a health care practitioner, while hydroxyhomosildenafil and thiosildenafil are unauthorized substances similar to sildenafil and may pose similar health risks.
- ArimaDex & Clomed [2010-12-16]
The U.S. Food and Drug Administration informed consumers that these products are being voluntarily recalled because they may contain an aromatase inhibitor, which is a prescription drug and should only be taken under the supervision of a health care practitioner.
November
- TimeOut [2010-11-29]
The U.S. FDA warned consumers not to buy or use TimeOut after it was found to contain undeclared hydroxythiohomosildenafil, which is an unauthorised substance similar to the prescription drug sildenafil and may pose similar health risks. Prescription drugs should only be used under the supervision of a health care practitioner.
- Solo Slim Extra Strength , Revivexxx Extra Strength [2010-11-29]
The U.S. Food and Drug Administration informed consumers of a company recall after Solo Slim Extra Strength was found to contain undeclared didesmethyl sibutramine, which is an unauthorized substance similar to sibutramine and may pose similar health risks, and Revivexxx Extra Strength was found to contain the undeclared prescription drug tadalafil. Sibutramine is no longer authorized for sale in Canada while tadalafil is a prescription drug and should only be used under the supervision of a health care practitioner.
- So Hard for Men , Pulse8 for Women , The Rock ,Tonic 66 [2010-11-29]
Zealand's MedSafe warned consumers to not buy or use these products after they were found to contain the undeclared pharmaceutical substances tadalafil, sildenafil, and/or hydroxyhomosildenafil. Sildenafil and tadalafil are prescription drugs and should only be taken under the supervision of a health care practitioner, while hydroxyhomosildenafil is an unauthorized substance similar to sildenafil and may pose similar health risks.
- Mr. Magic Male Enhancer from Don Wands [2010-11-29]
The U.S. Food and Drug Administration informed consumers of a company recall of certain lots (see Alert for lot numbers) of this product after they were found to contain hydroxythiohomosildenafil and sulfoaildenafil, which are unauthorized substances similar to sildenafil and may pose similar health risks. Sildenafil is a prescription drug and should only be taken under the supervision of a health care practitioner.
- MasXtreme [2010-11-29]
The U.S. FDA informed consumers of a recall of two lots of MasXtreme because one (#907043) contains undeclared aminotadalafil while the other (#911035) contains undeclared aildenafil and phentolamine. Aminotadalafil and aildenafil are unauthorized substances that are similar to the prescription drugs tadalafil and sildenafil and may pose similar health risks, while phentolamine is a prescription drug and should only be used under the supervision of a health care practitioner.
- Goya-Bitter Melon , Miyura Fit'x Capsules , 2 unnamed/unknown products (see Alert for photos) [2010-11-29]
The Hong Kong Department of Health found these four products to contain undeclared phenolphthalein and sibutramine, both of which are pharmaceutical substances that are no longer authorized for sale in Canada due to the risk of serious health effects.
- 101 Zhangguang Gold 101 Super Effective Hair Growth Agent and 101 Zhangguang Fabao 101D Doctor Zhao's Chinese Traditional Herbal Hair Care Formula [2010-11-22]
The Hong Kong Department of Health warned consumers not to buy or use these two products after they were found to contain undeclared minoxidil.
- Beijing 101 Hair Consultants Hair Growth Formula D-2653-B and Hair Growth Tonic E-0583-D [2010-11-22]
The Singapore Health Sciences Authority advised consumers to stop using one batch of these products (Beijing 101 Hair Consultants Hair Growth Formula D-2653-B batch# 20091201, and Hair Growth Tonic E-0583-D batch# 20091201)after testing of these batches revealed the presence of undeclared minoxidil.
- Amana Care Seven Slim Herbal Capsules [2010-11-22]
The Israel Ministry of Health informed consumers that it found this product to contain undeclared sibutramine and residue of sildenafil. Sibutramine is no longer authorized for sale in Canada due to its association with an increased risk of cardiovascular side effects such as heart attack and stroke. Sildenafil is a prescription drug and should only be used under the supervision of a health care practitioner.
- Arrow Brand Medicated Oil & Embrocation [2010-11-22]
The U.S. Food and Drug Administration warned consumers not to buy or use this product (which also comes labelled in Spanish and Mandarin) because it contains ingredients that are potentially poisonous, particularly in children. The ingredients of concern are methyl salicylate, camphor and eucalyptus oil. The product packaging recommends oral or topical use but does not provide specific guidance or dosing instructions, which may increase the risk of toxicity.
September
- Golden aryuru, Baisheng wei ge, Zhonghua niubian, Ten ka dai 1 bou, Kuai gan bei zeng chao yue zi wo (Happy felling doubly increase [sic]), Ling tou lang, SkyFruit, Chu bi ho ken, Jinbolang, Suika Koso, Lov, I ka ou (2009 nen sin hoso) and/or I ka ou (saisinsui shutsu hoso) [2010-09-20]
The Japanese Ministry of Health, Labour and Welfare warned consumers not to buy or use these products because they were found to contain sildenafil and/or other unauthorized substances similar to sildenafil that may pose similar health risks (norhongdenafil, acetil acid, and tioqinapiperifil). Sildenafil is a prescription drug and should only be used under the supervision of a health care practitioner.
- Joyful Slim Herb Supplement [2010-09-20]
The U.S. Food and Drug Administration informed consumers of a company recall of this product after one lot (#101408) was found to contain undeclared desmethyl sibutramine. Desmethyl sibutramine is an unauthorized substance similar to sibutramine, a prescription drug used to treat obesity, and may pose similar health risks. Sibutramine should only be used under the supervision of a health care practitioner.
- Vialipro [2010-09-20]
The U.S. Food and Drug Administration informed consumers of a company recall of certain lots (see Alert for a list of lot numbers) of this product after samples were found to contain sulfoaildenafil, which is an unauthorized substance similar to sildenafil and may pose similar health risks. Sildenafil is a prescription drug and should only be taken under the supervision of a health care practitioner.
July
- Sheng Yuan Fang [2010-07-29]
The Hong Kong Department of Health warned consumers not to buy or use Sheng Yuan Fang because it contains undeclared phenolphthalein and sibutramine. Phenolphthalein is no longer authorized for sale in Canada because it may cause cancer while sibutramine is a prescription drug and should only be used under the supervision of a health care practitioner.
- Kam Chik San [2010-07-29]
The Hong Kong Department of Health cautioned against this product, which is promoted for use in children, because it contains excessive levels of mercury. Ingestion of excessive amounts of mercury, which is a heavy metal, poses serious health risks because it may accumulate in vital organs of the body. Children are most susceptible to the toxic effects.
- Que She [2010-07-29]
The U.S. Food and Drug Administration warned consumers not to buy or use Que She because it was found to contain undeclared propranolol, sibutramine, fenfluramine and ephedrine. Propranolol and sibutramine are prescription drugs and should only be used under the supervision of a health care practitioner, while fenfluramine is not authorized for sale in Canada and ephedrine is not authorized for use in a weight loss product.
- Magic Power Coffee [2010-07-29]
The U.S. Food and Drug Administration warned consumers not to buy or use this product because it contains hydroxythiohomosildenafil, an unauthorized substance similar to sildenafil. Sildenafil is a prescription drug and should only be taken under the supervision of a health care practitioner.
- Huo Luo Jing Dan [2010-07-29]
The Singapore Health Sciences Authority warned consumers not to buy or use this product because it contains three undeclared prescription drugs: indomethacin, dexamethasone and prednisolone. These drugs should only be used under the supervision of a health care practitioner.
- Vitalex for men and Vitalex for women [2010-07-14]
The U.S. Food and Drug Administration Office of Criminal Investigations informed consumers that two people had been charged with distributing misbranded drugs after Vitalex for men and Vitalex for women were found to contain acetildenafil, an unauthorized substance similar to sildenafil. Sildenafil is a prescription drug and should only be taken under the supervision of a health care practitioner.
- Stallion, SZM Formula for Men, Tomcat Ali and Volcanic [2010-07-14]
New Zealand's Medsafe advised consumers to immediately stop using these products after they were found to contain undeclared tadalafil. Tadalafil is a prescription drug and should only be taken under the supervision of a health care practitioner. Medsafe ordered the immediate recall of these products.
- **Update** Atlas Operations Inc. expands its U.S. recall of over 30 sexual enhancement supplements (see Foreign Product Alert for an updated list or recalled products) [2010-07-14]
The U.S. FDA informed consumers of an expanded recall by Atlas Operations Inc. Certain lots of over 30 products promoted for sexual enhancement are being voluntarily recalled after some products were found to contain undeclared sulfoaildenafil, which is an unauthorized substance similar to sildenafil and may pose similar health risks. Sildenafil is a prescription drug and should only be used under the supervision of a health care practitioner.
- USA Yaku Cell Slimming Capsules, Dong Gua Pai You Su, Qing Gua Pai You Su, and Mu Gua Pai You Su [2010-07-14]
The Hong Kong Department of Health warned consumers not to buy or use these four products because they contain undeclared phenolphthalein, sibutramine and an unauthorized substance similar to sibutramine. Phenolphthalein is no longer authorized for sale in Canada because it may cause cancer while sibutramine is a prescription drug and should only be used under the supervision of a health care practitioner.
- 1 Body Beautiful [2010-07-14]
The Hong Kong Department of Health warned consumers not to buy or use this product because it contains undeclared phenolphthalein and sibutramine. Phenolphthalein is no longer authorized for sale in Canada because it may cause cancer, while sibutramine is a prescription drug and should only be used under the supervision of a health care practitioner.
- Stud Capsule For Men [2010-07-05]
The U.S. FDA informed consumers of a voluntary recall of one lot (Lot #060607-01/060108-01 Exp 6-2013) after it was found to contain undeclared Sildenafil. Sildenafil is a prescription drug and should only be taken under the supervision of a health care practitioner.
- Po Chai Pills (capsule form) [2010-07-05]
The Hong Kong Department of Health warned consumers not to buy or use this product after it was found to contain undeclared sibutramine and phenolphthalein. Sibutramine is a prescription drug and should only be used under the supervision of a health care practitioner while phenolphthalein is no longer authorized for sale in Canada because it may cause cancer. Po Chai Pills (capsule form) has been recalled by the manufacturer.
- LiPO-4 Cap, LiPO-8 Cap and Glucomi 600 Cap [2010-07-05]
The Hong Kong Department of Health warned consumers not to buy or use these products because they contain undeclared sibutramine. Sibutramine is a prescription drug and should only be used under the supervision of a health care practitioner.
June
- Vita Breath [2010-06-16]
The U.S. FDA warned consumers not to buy or consume Vita Breath because it may contain hazardous levels of lead, which is a heavy metal. Ingestion of excessive amounts of heavy metals can pose serious health risks, particularly to children.
- Qingzhi Santian Shou [2010-06-16]
The Hong Kong Department of Health warned consumers not to buy or use this product because it contains undeclared sibutramine and an unauthorized substance similar to sibutramine. Sibutramine is a prescription drug and should only be used under the supervision of a health care practitioner. Phenolphthalein is no longer authorized for sale in Canada because it may cause cancer.
- COMECOO, ZHONGCAOYAO-JIANKANGJIANFEI [2010-06-16]
The Hong Kong Department of Health warned consumers not to buy or use these two products because they contain undeclared phenolphthalein, sibutramine and two unauthorized substances similar to sibutramine. Phenolphthalein is no longer authorized for sale in Canada because it may cause cancer and sibutramine is a prescription drug and should only be used under the supervision of a health care practitioner.
May
- S&S Super Slender [2010-05-17]
The Hong Kong Department of Health warned consumers not to buy or use S&S Super Slender after two samples were found to contain an unauthorized substance similar to sibutramine. One of the tested samples also contained undeclared sibutramine and phenolphthalein. Sibutramine is a prescription drug and should only be used under the supervision of a health care practitioner while phenolphthalein is no longer authorized for sale in Canada because it may cause cancer.
- Marsha Slim Plus [2010-05-17]
The Hong Kong Department of Health warned consumers not to buy or use this product because it contains undeclared sibutramine, an unauthorized substance similar to sibutramine and phenolphthalein. Sibutramine is a prescription drug and should only be used under the supervision of a health care practitioner while phenolphthalein is no longer authorized for sale in Canada because it may cause cancer.
- Botanical Slimming 100% Natural Soft Gel, also sold as Meizitang [2010-05-17]
The Australian Therapeutic Goods Administration warned consumers not to buy or use this product because it contains undeclared sibutramine. Sibutramine is a prescription drug and should only be used under the supervision of a health care practitioner.
- Seven Slim 7 Seshou (Qingchun Shaonüxing), Seven Slim 7 Seshou (Jieshixing), Seven Slim 7 Seshou (Guifurenxing), Seven Slim 7 Seshou (Songchixing), Shoushen Jiaoguan-Tinei Yundong Wan (Jian Xiabanshen), Shoushen Jiaoguan-Tinei Yundong Wan (Jian Quanshen Feipang) [2010-05-03]
The Hong Kong Department of Health warned consumers not to buy or use these six products because they contain undeclared sibutramine and phenolphthalein. Sibutramine is a prescription drug and should only be used under the supervision of a health care practitioner while phenolphthalein is no longer authorized for sale in Canada because it may cause cancer.
- 17 products sold through MuscleMaster.com(see Foreign Product Alert for a complete product list) [2010-05-03]
The FDA informed consumers of a voluntary recall by MuscleMaster.com of 17 bodybuilding products as these products may contain anabolic steroids. In Canada, anabolic steroids are controlled substances and are therefore only legally available by prescription. They should only be taken under the supervision of a health care practitioner.
- Man Power [2010-05-03]
The Hong Kong Department of Health warned consumers not to buy or use this product because it contains undeclared Tadalafil. Tadalafil is a prescription drug and should only be taken under the supervision of a health care practitioner.
- Lin Yan Yin Chiao [2010-05-03]
The Singapore Health Sciences Authority issued a recall notice for one batch (batch# JI0324, expiry date 03/2011) of Lin Yan Yin Chiao because it contains undeclared chlorpheniramine and paracetamol. Chlorpheniramine is an over-the-counter antihistamine drug, while paracetamol (also known as acetaminophen) is an ingredient used in both over-the-counter and prescription drugs to treat fever and pain.
- Bao Shu Tang Wu Zi Yan Zong Wan [2010-05-03]
The Hong Kong Department of Health warned consumers not to buy or use this product because it contains excessive levels of lead, which may pose serious health risks.
- Ba Bao Xiao Ke Dan [2010-05-03]
The Hong Kong Department of Health warned consumers not to buy or use this product because it contains undeclared glibenclamide, which is a prescription drug and should only be used under the supervision of a health care practitioner.
March
- Tian Yang Xu Huo Oral Ulcer Capsule [2010-03-01]
The Singapore Health Sciences Authority issued a recall notice for one batch (batch number 0812003, expiry date 11.2011) of this product after it was found to contain undeclared aristolochic acid, a naturally occurring toxic substance associated with serious health risks such as kidney failure and cancer.
- STRO Emperor Capsules [2010-03-01]
The Irish Medicines Board warned consumers not to buy or use this product because it contains undeclared Tadalafil. Tadalafil is a prescription drug and should only be taken under the supervision of a health care practitioner.
- 65 products sold through Bodybuilding.com [2010-03-01]
The FDA informed consumers of a voluntary recall by Bodybuilding.com of 65 bodybuilding products as these products may contain anabolic steroids. In Canada, anabolic steroids are controlled substances and are therefore only legally available by prescription. They should only be taken under the supervision of a health care practitioner.
- Certain lots (Lot Numbers 494, 520, 520A, 520B, 520C, 521, 705, 706, 779 and 807) of sexual enhancement dietary supplements sold by Atlas Operations Inc. (see Foreign Product Alert for a product list) [2010-03-01]
The U.S. FDA informed consumers of a voluntary recall by Atlas Operations Inc. of certain product lots after some products were found to contain undeclared sulfoaildenafil, which is an unauthorized substance similar to sildenafil. Sildenafil is a prescription drug and should only be used under the supervision of a health care practitioner.
- 2H & 2D [2010-03-01]
The Hong Kong Department of Health warned consumers not to buy or use this product because it contains undeclared Tadalafil. Tadalafil is a prescription drug and should only be taken under the supervision of a health care practitioner.
January
- Ku Xiu Ba Xiang Jian Fei Wan, Super Slim (Yani), SHoufsy and MIGAC (sic) FAT BURMING (sic) FACTOR [2010-01-06]
The Hong Kong Department of Health warned consumers not to buy or use these four products because they contain undeclared sibutramine. As well, Ku Xiu Ba Xiang Jian Fei Wan contains an unauthorized substance similar to sibutramine and Super Slim (Yani) contains phenolphthalein. Sibutramine is a prescription drug and should only be used under the supervision of a health care practitioner. Phenolphthalein is no longer authorized for sale in Canada because it may cause cancer.
- 1) RockHard Weekend (certain lots) and 2) Pai You Guo [2010-01-06]
The U.S. FDA informed consumers of a voluntary recall of certain lots of RockHard Weekend because they contain undeclared sulfoaildenafil, which is an unauthorized substance similar to sildenafil. The FDA also informed consumers of a voluntary recall of Pai You Guo because it contains undeclared sibutramine and phenolphthalein. Sildenafil and sibutramine are prescription drugs and should only be used under the supervision of a health care practitioner. Phenolphthalein is no longer authorized for sale in Canada because it may cause cancer.
- M-Action [2010-01-06]
The Singapore Health Sciences Authority issued a recall notice for one batch (batch CA009A08F, expiry date 15/01/2011) of M-Action because it contains undeclared desmethylacetildenafil and acetilacid, which are unauthorized substances similar to sildenafil. Sildenafil is a prescription drug and should only be taken under the supervision of a health care practitioner.
- Full Contact Max Potency [2010-01-06]
The Finnish Food Safety Authority, Evira, recalled Full Contact Max Potency because it contains undeclared thio-sildenafil and thio-homosildenafil, which are unauthorized substances similar to sildenafil. Sildenafil is a prescription drug and should only be taken under the supervision of a health care practitioner.
Drugs and natural health products that are authorized for sale in Canada will have either 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.
Health Canada advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find any of the products listed above in the Canadian marketplace.
For more information about the information contained in this advisory, please contact Health Canada's public enquiries line at (613) 957-2991 or toll-free at 1-866-225-0709.
As of the date of this posting, no adverse reactions suspected to be associated with the use of these products have been reported in Canada.
To report a suspected adverse reaction, please visit the MedEffect Adverse Reaction Reporting page.