Saturday, May 11, 2019

Unauthorized foreign health products have been found by regulators in the United States, Singapore and Australia.




Foreign product alert (FPA)

Starting date:
May 10, 2019
Type of communication:
Foreign Product Alert (FPA)
Subcategory:
Miscellaneous, Drugs
Source of recall:
Health Canada
Issue:
Undeclared Substance
Audience:
General Public
Identification number:
RA-69842

Last updated: 

Products Alerts

These foreign health products have been found by regulators in the United States, Singapore and Australia to contain undeclared drug ingredients which may pose serious health risks.
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.
U.S. Food and Drug Administration - United States
Product nameHazard identifiedDetailsPhoto
5KUndeclared sildenafilSexual enhancement capsules
AB SlimUndeclared sibutramine, phenolphthalein and sildenafilWeight loss capsules
Adipotrim XTUndeclared phenolphthaleinWeight loss capsules
Adriana Balance SUndeclared sibutramineWeight loss capsules
African SupermanUndeclared sildenafilSexual enhancement tablets
African ViagraUndeclared sildenafilSexual enhancement pills
AsunsaUndeclared sibutramine, N-desmethylsibutramine, benzylsibutramine, phenolphthalein and diclofenacWeight loss sachets
Baschi Quick Slimming CapsuleUndeclared sibutramine and N-desmethylsibutramineWeight loss capsules
Best CandyUndeclared nortadalafilEnergy booster candy
Black Rhino 25000Undeclared sildenafilSexual enhancement capsules
Black Stallion 35000Undeclared sildenafilSexual enhancement capsules
Body Shape Weight Loss SystemUndeclared phenolphthaleinWeight loss capsules
BodySlim HerbalUndeclared sibutramineWeight loss capsules
Boss Rhino 15000Undeclared sildenafilSexual enhancement capsules
Botanical SlimmingUndeclared adulterantWeight loss capsules
C.U. PlusUndeclared sildenafil and tadalafilSexual enhancement
Chong Cao Qiang Shen WangUndeclared sildenafilGrains
Dale MasUndeclared sildenafil and tadalafilSexual enhancement
Ding Ji Wei GeUndeclared sildenafilSexual enhancement
Easy 2 SlimUndeclared sibutramineWeight loss capsules
Extenze NutritionalUndeclared sildenafilSexual enhancement capsules
Extenze PlusUndeclared sildenafilSexual enhancement capsules
Jimpness Fat Loss Slimming BeautyUndeclared sibutramine andphenolphthaleinWeight loss
FRUTA BioUndeclared sibutramine and phenolphthaleinWeight loss capsules
FRUTA PlantaUndeclared sibutramine and phenolphthaleinWeight loss capsules
FX75000Undeclared sildenafilSexual enhancement capsules
Gold Rhino 25000Undeclared sildenafilSexual enhancement capsules
Gold ViagraUndeclared sildenafilSexual enhancement
Grakcu CapsuleUndeclared sildenafil and tadalafilSexual enhancement capsules
Green Lean Body CapsuleUndeclared sibutramine and N-desmethylsibutramineWeight loss capsules
In ShapeUndeclared sibutramineWeight loss capsules
JIANFEIJINDAN Activity GirlUndeclared sibutramineWeight loss capsules
Krazzy Rhino 25000Undeclared sildenafilSexual enhancement capsules
Lean Extreme MaxUndeclared sibutramineWeight loss capsules
Lyn DTOX FS3Undeclared sibutramine and N-desmethylsibutramineWeight loss capsules
Magic SlimUndeclared sibutramineWeight loss capsules
MaxidusUndeclared sildenafilSexual enhancement capsules
Maximum PowerfulUndeclared sildenafilSexual enhancement
Meizi EvolutionUndeclared sibutramineWeight loss capsules
Meizitang Strong VersionUndeclared sibutramineWeight loss capsules
NuvitraUndeclared sibutramine and fluoxetineWeight loss
On DemandUndeclared sildenafilSexual enhancement capsules
Panther Power Platinum 11000Undeclared sildenafilSexual enhancement capsules
PAYA Dietary Supplement ProductUndeclared sibutramineWeight loss capsules
Platinum Maximum Strength Blue Pill VersionUndeclared sibutramine and phenolphthaleinWeight loss capsules
Platinum Rhino 25000Undeclared sildenafilSexual enhancement capsules
PremierZen Gold 4000Undeclared sildenafilSexual enhancement capsules
ProSolutionUndeclared sildenafilSexual enhancement tablets
Row of Antibody PilUndeclared sibutramine and phenolphthaleinWeight loss pills
Shengan Natural ModelUndeclared sibutramineWeight loss
Slim BodyUndeclared adulterantWeight loss
Slim EvolutionUndeclared diclofenacWeight loss capsules
Slim XtremeUndeclared sibutramineWeight loss capsules
SlimEasy HerbsUndeclared sibutramineWeight loss capsules
Slimming CapsuleUndeclared sibutramine and phenolphthaleinWeight loss capsules
Slimming Plus Advanced Weight LossUndeclared sibutramine and phenolphthaleinWeight loss capsules
Strong HorsesUndeclared sildenafilSexual enhancement capsules
Super Fat Burning BombUndeclared sibutramine and phenolphthaleinWeight loss capsules
USA for WomenUndeclared sildenafilSexual enhancement
V-MaxUndeclared sildenafilSexual enhancement tablets
X-treme Beauty SlimUndeclared sibutramineWeight loss capsules
XXXPlosionUndeclared sildenafilSexual enhancement
XXXPlosion UltraUndeclared sildenafilSexual enhancement
Health Science Authority - Singapore
AUSBEE AUSTRALIA AUSBEE HerbalUndeclared dexamethasone,
chloramphenicol, chlorpheniramine, ibuprofen
and tetracycline
Powder Capsules
Pil Raja Urat AsliUndeclared dexamethasone
SHEN LOON SHE EDOLYUndeclared dexamethasone and chlorpheniramineCapsules
Sparkle TwinsUndeclared sibutramineWeight loss sachets
XXS xtraxtrasmallUndeclared sibutramineWeight loss capsules
Therapeutic Goods Administration - Australia
Big Penis U.S.A.Undeclared sildenafil and chloramphenicolSexual enhancement tablets
Bulbao Male EnhancerUndeclared sildenafil, tadalafil and yohimbineSexual enhancement tablets
Chapter Plus+Undeclared sibutramineWeight loss capsules
FairyUndeclared sibutramineCapsules
G FemaleUndeclared sildenafilTablets
Germany NiubianUndeclared sildenafilTablets
Hypnotic poisom capsulesUndeclared 
sibutramine and phenolphthalein
Capsules
Lanky GenuineUndeclared sibutramine and phenolpthaleinCapsules
Li DaUndeclared sibutramineWeight loss capsules
Liangzern Dietary SupplementsUndeclared sildenafilWeight loss tablets
Lishou Strong Slimming capsuleUndeclared sibutramineWeight loss capsules
Meltz - Instant Energy For MalesUndeclared vardenafilTablets
Mutant YK-11 CapsulesUndeclared tadalafilCapsules
Platinum Male EnhancerUndeclared sildenafil and sulfoaildenafilSexual enhancement capsules
Rhino 8 Platinum 8000 capsulesUndeclared sildenafilCapsules
Solve Botanical Slimming capsulesUndeclared furosemide (frusemide), phenolphthalein and paracetamolWeight loss capsules
You Slim'xs capsulesUndeclared sibutramineWeight loss capsules

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 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.
Chloramphenicol is a prescription antibiotic drug. Side effects include abdominal pain, allergic reactions, and bone marrow failure (aplastic anemia).
  • Chlorpheniramine is a non-prescription antihistamine drug. Side effects include drowsiness, dizziness, confusion and blurred vision.
  • Dexamethasone is a steroidal prescription drug used to treat inflammatory conditions such as arthritis and allergic reactions. Side effects include irregular heartbeat, increased blood pressure, stomach ulcer, blood disorders, skin, muscle and bone damage, and nervous system disorders. Consult with your healthcare professional before stopping use, as sudden discontinuation  may cause symptoms of withdrawal.
  • Diclofenac is an oral 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.
  • Fluoxetine is a prescription drug used to treat depression. Side effects include headache, sleeping problems, anxiety, nausea, loss of appetite and excessive sweating.
  • Furosemide is a diuretic (water pill) prescription drug used to remove excess fluid from the body. Side effects include changes in electrolytes (specifically potassium), muscle cramps, dizziness, low blood pressure, headache and nausea.
  • Ibuprofen is a (prescription and/or non-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.
  • Paracetamol, also known as acetaminophen, is an ingredient used in both non-prescription and prescription drugs to treat fever and pain. Long-term use of high doses of acetaminophen may cause serious liver damage.
  • 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.
  • Sildenafil,Tadalafil and Vardenafil are prescription drugs used to treat erectile dysfunction. They 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.
  • Tetracycline is a prescription antibiotic drug. Side effects include abdominal pain, nausea, vomiting, diarrhea, light-headedness, dizziness, and ringing in the ears (tinnitus). Other side effects include red rash on sun-exposed skins, and liver and kidney injuries. Tetracycline is also associated with permanent teeth discolouration and delayed bone growth in young children.
  • Yohimbine is a prescription drug used to treat abnormal blood pressure. Side effects include abnormal blood pressure and heartbeat, anxiety, tremors, headache, nausea and sleep disorders.

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
As of April 3, 2019, no adverse reactions suspected to be associated with the use of these products have been reported to Health Canada.

For more information

Images

Select thumbnail to enlarge
Undeclared sildenafil
Undeclared sibutramine, phenolphthalein and sildenafil
Undeclared phenolphthalein
Undeclared sibutramine
Undeclared sildenafil
Undeclared sildenafil
Undeclared sibutramine, N-desmethylsibutramine, benzylsibutramine, phenolphthalein and diclofenac
Undeclared sibutramine and N-desmethylsibutramine
Undeclared nortadalafil
Undeclared sildenafil
Undeclared sildenafil
Undeclared phenolphthalein
Undeclared sibutramine
Undeclared sildenafil
Undeclared adulterant
Undeclared sildenafil and tadalafil
Undeclared sildenafil
Undeclared sildenafil and tadalafil
Undeclared sildenafil
Undeclared sibutramine
Sexual enhancement capsules
Undeclared sildenafil
Undeclared sibutramine andphenolphthalein
Undeclared sibutramine and phenolphthalein
Undeclared sibutramine and phenolphthalein
Undeclared sildenafil
Undeclared sildenafil
Undeclared sildenafil
Undeclared sildenafil and tadalafil
Undeclared sibutramine and N-desmethylsibutramine
Undeclared sibutramine
Undeclared sibutramine
Undeclared sildenafil
Undeclared sibutramine
Undeclared sibutramine and N-desmethylsibutramine
Undeclared sibutramine
Undeclared sildenafil
Undeclared sildenafil
Undeclared sibutramine
Undeclared sibutramine
Undeclared sibutramine and fluoxetine
Undeclared sildenafil
Undeclared sildenafil
Undeclared sibutramine
Undeclared sibutramine and phenolphthalein
Undeclared sildenafil
Undeclared sildenafil
Undeclared sildenafil
Undeclared sibutramine and phenolphthalein
Undeclared sibutramine
Undeclared adulterant
Undeclared diclofenac
Undeclared sibutramine
Undeclared sibutramine
Undeclared sibutramine and phenolphthalein
Undeclared sibutramine and phenolphthalein
Undeclared sildenafil
Undeclared sibutramine and phenolphthalein
Undeclared sildenafil
Undeclared sildenafil
Undeclared sibutramine
Undeclared sildenafil
Undeclared sildenafil
Undeclared dexamethasone,
chloramphenicol, chlorpheniramine, ibuprofen
and tetracycline
Undeclared dexamethasone
Undeclared dexamethasone and chlorpheniramine
Undeclared sibutramine
Undeclared sibutramine
Undeclared sildenafil and chloramphenicol
Undeclared sibutramine
Undeclared sildenafil
Undeclared sildenafil
Undeclared 
sibutramine and phenolphthalein
Undeclared sibutramine and phenolpthalein
Undeclared sibutramine
Undeclared sildenafil
Undeclared sibutramine
Undeclared vardenafil
Undeclared sildenafil and sulfoaildenafil
Undeclared sildenafil
Undeclared furosemide (frusemide), phenolphthalein and paracetamol
Undeclared sibutramine
Undeclared tadalafil
Undeclared sibutramine
Undeclared sibutramine
Undeclared sildenafil, tadalafil and yohimbine

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