Advisories, Warnings & Recalls
AUGUST 2010
Droperidol Injection USP - Association with Severe Arrhythmia - Sandoz Canada Inc.
http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/droperidol_2_hpc-cps-eng.php
2010-08-30
Delivery of Topical Hemostatic Agents Using Spray Devices - Association with Air/Gas Embolism
http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/hemostat_agent_2_nth-aah-eng.php
2010-08-27
Important Diabetes Information: GlucaGen Hypokit being Recalled in Canada
http://hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_145-eng.php
2010-08-25
AVASTIN (bevacizumab) - Association with Allergic Reactions - Hoffmann-La Roche Limited
http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/avastin_5_hpc-cps-eng.php
2010-08-23
zumab) - Association with Allergic Reactions - Hoffmann-La Roche Limited
http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/avastin_5_hpc-cps-eng.php
2010-08-23
Adrenalin (epinephrine chloride 1:1000) Intended for Topical Use - Risk of Inadvertent Injection - Erfa Canada Inc.
http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/adrenalin_hpc-cps-eng.php
2010-08-03
RELISTOR (methylnaltrexone bromide) Subcutaneous Injection - Association with gastrointestinal perforation - Wyeth Canada
http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/relistor_hpc-cps-eng.php
2010-08-03
JULY 2010
RotaTeq - Presence of Porcine Circovirus (PCV) DNA - Merck Frosst Canada Ltd.
http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/rotateq_hpc-cps-eng.php
2010-07-30
Rotarix - Presence of Porcine Circovirus Type 1 (PCV-1) - GlaxoSmithKline Inc.
http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/rotarix_hpc-cps-eng.php
2010-07-30
JUNE 2010
MIRENA (Levonorgestrel-Releasing Intrauterine System) - Potential Risk of Uterine Perforation - Bayer Inc.
http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/mirena_hpc-cps-eng.php
2010-06-17
CANCIDAS (caspofungin acetate for injection) - Voluntary Product Recall - Merck Frosst Canada Ltd.
http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/cancidas_nth-aah-eng.php
2010-06-15
Baxter Colleague Volumetric Infusion Pumps - Information for Canadian health care facilities related to the recall in the United States
http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/infusion-perfusion_pump-pompe_8_nth-aah-eng.php
2010-06-11
CIPROFLOXACIN INJECTION - Voluntary Recall - BioSyent Pharma Inc.
http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/ciprofloxacin_nth-aah-eng.php
2010-06-09
CHAMPIX (varenicline tartrate) - Changes to the Canadian Product Monograph - Pfizer Canada Inc.
http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/champix_2_hpc-cps-eng.php
2010-06-03
MAY 2010
RISPERDAL CONSTA (risperidone powder for injectable prolonged-release suspension) - Needle Detachments Associated with the Needle Assembly Used for Gluteal Injection - Janssen-Ortho Inc.
http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/risperdal_consta_hpc-cps-eng.php
2010-05-25
TYSABRI (natalizumab) - New Safety Information Regarding Progressive Multifocal Leukoencephalopathy (PML) - Biogen Idec Canada Inc
http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/tysabri_3_hpc-cps-eng.php
2010-05-17
Cuffed Shiley Tracheostomy Products - Health Canada Endorsed Important Safety Information - Tyco Healthcare Canada
http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/trach_tubes_nth-aah-eng.php
2010-05-13
Exelon Patch (timbre transdermique de rivastigmine) - Effets indésirables graves associés aux erreurs médicamenteuses ou au mésusage - Novartis Pharma Canada inc.
http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/exelon_hpc-cps-fra.php
2010-05-05
APRIL 2010
Invirase (saquinavir mesylate) - Association with Dose-Dependent Abnormal Electrical Activity or Conduction in the Heart (Prolongations of QT and PR Intervals) in Healthy Volunteers - Hoffmann-La Roche Limited
http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/invirase_hpc-cps-eng.php
2010-04-20
Zeftera (ceftobiprole medocaril) for Injection - Discontinuation of Sale - Janssen-Ortho Inc.
http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/zeftera_nth-aah-eng.php
2010-04-16
MARCH 2010
Fentanyl Transdermal Systems - New Changes to the Dose Conversion Guidelines - Janssen-Ortho Inc., Cobalt Pharmaceuticals Inc., Teva Canada Limited, Ranbaxy Pharmaceuticals Canada Inc., ratiopharm inc., Sandoz Canada Inc. and Pharmascience Inc.
http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/zeftera_nth-aah-eng.php
2010-03-10
FEBRUARY 2010
Accutane (isotretinoin) - Association with Cases of Severe Skin Reactions - Hoffmann-La Roche Limited
http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/accutane_2_hpc-cps-eng.php
2010-02-16
Surgical Mesh - Complications Associated with Transvaginal Implantation of Surgical Mesh for the Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse
http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/surgical-mesh_nth-aah-eng.php
2010-02-05
JANUARY 2010
OPTIMARK (gadoversetamide injection) - Association with Nephrogenic Systemic Fibrosis (NSF) in Patients with Renal Impairment - Tyco Healthcare (Covidien)
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/optimark_hpc-cps-eng.php
2010-01-12
DECEMBER 2009
Cerezyme (imiglucerase for injection) - Supply and Recommendations for Restarting Cerezyme - Genzyme Canada Inc.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/cerezyme_hpc-cps-eng.php
2009-12-29
Myfortic (mycophenolate sodium) - Reports of Pure Red Cell Aplasia in Patients - Novartis Pharmaceuticals Canada Inc.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/myfortic_hpc-cps-eng.php
2009-12-23
Thyrogen (thyrotropin alfa for injection): Caution with Preparation and Administration - Genzyme
http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/thyrogen_hpc-cps-eng.php
2009-12-09
Important Information about Acai Berry Products containing Prescription Medication
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2009/2009_197-eng.php
2009-12-08
One Lot of Zaditen Tablets (for Asthma) Recalled Due to Potential Health Risks
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2009/2009_194-eng.php
2009-12-04
Exjade (deferasirox) - Proposed Changes to the Canadian Product Monograph - Novartis Pharmaceuticals Canada Inc.
http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/exjade_3_hpc-cps-eng.php
2009-12-03
Rapamune (sirolimus) - Blood Level Measurement Changes
http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/rapamune_4_hpc-cps-eng.php
2009-12-02
NOVEMBER 2009
Heparin - Decreased Potency as a Result of New United States Pharmacopeia (USP) Standards
http://hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2009/2009_191-eng.php
2009-11-26
Foreign Particles Found In Certain Products From Genzyme
http://hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2009/2009_190-eng.php
2009-11-25
Authorization for Sale and Post-Market Activities for Arepanrix H1N1 Vaccine - GlaxoSmithKline Inc.
http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/arepanrix_h1n1_hpc-cps-eng.php
2009-11-16
Association of Relenza (zanamivir) dry powder for inhalation with fatal outcome when administered by nebulization instead of inhalation - GlaxoSmithKline
http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/relenza_nth-aah-eng.php
2009-11-05
OCTOBER 2009
Type I Product Recall of Propofol Injection, 1 g/100 mL and 500 mg/50 mL Due to the Presence of Particulate Matter - Hospira Healthcare Corporation - For Health Professionals
http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/propofol_hpc-cps-eng.php
2009-10-30
Type II Product Recall of Apo-Lithium Carbonate SR 300 mg strength tablets - Apotex Inc.
http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/apo-lithium_hpc-cps-eng.php
2009-10-28
Potential Risk of Serious Adverse Health Consequences with Inadvertent Administration of Cesamet (nabilone) Capsules 1 mg Instead of Trazorel (trazodone hydrochloride) Tablets 50 mg Due to Mislabelling - Valeant Canada Limited
http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/cesamet_hpc-cps-eng.php
2009-10-26
Important Tamiflu Information for Health Professionals
http://hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2009/2009_172-eng.phphttp://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/rituxan_5_hpc-cps-eng.php
2009-10-23
Association of Rituxan (rituximab) with Progressive Multifocal Leukoencephalopathy (PML) - Hoffmann-La Roche Limited
http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/rituxan_5_hpc-cps-eng.php
2009-10-23
Health Canada issued important safey information on CEFTRIAXONE
http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/ceftriaxone_2_nth-aah-eng.php
2009-10-20
New Safety Information Regarding Intelence (etravirine) and Severe Skin and Hypersensitivity Reactions - Tibotec, a division of Janssen-Ortho Inc.
2009-10-19
http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/intelence_hpc-cps-eng.php
Important Information About the Risk of Dosing Error for Tamiflu (oseltamivir phosphate) Powder for Oral Suspension (12 mg/mL) - Hoffmann-La Roche Limited
2009-10-15]
http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/tamiflu_2_hpc-cps-eng.php
Important Safety Information on Hospira Devices that have Defective AC Power Cords - Hospira Healthcare Corporation
2009-10-01
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/hospira_hpc-cps-eng.php
FDA Public Health Alert: Potential Medication Errors with Tamiflu for Oral Suspension
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm183649.htm
AUGUST 2009
Potential interaction of Proton Pump Inhibitors (PPIs) with Plavix (clopidogrel) - sanofi-aventis Canada Inc. and Bristol-Myers Squibb Canada Co.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/plavix_hpc-cps-eng.php
Date: 2009-08-20
Health Canada Reviewing Possible Association of Asthma Drug Xolair (Omalizumab) with Increased Risk of Cardiovascular Problems
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2009/2009_129-eng.php
Date: 2009-08-13
Important Safety Information on Medtronic Paradigm Quick-set Infusion Sets (Models MMT-396, MMT-397, MMT-398 and MMT-399)
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/infusion-perfusion_set-disp_nth-aah-eng.php
Date: 2009-08-06
Oral sodium phosphate products are no longer authorized for purgative use - Pharmascience Inc. and Odan Laboratories Ltd.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/oral_sodium_phos_hpc-cps-eng.php
Date: 2009-08-05
JULY 2009
Association of Telzir (fosamprenavir) with a potential increased risk of myocardial infarction (heart attack) - GlaxoSmithKline Inc.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/telzir_hpc-cps-eng.php
Date: 2009-07-22
JUNE 2009
Pms - Phenobarbital (60 mg) Being Recalled in Canada due to Risk of Accidental Overdose
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2009/2009_105-eng.php
Date: 2009-06-26
Updated Labelling for Piroxicam - Drug No Longer to be Used for Acute Pain or Inflammation
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2009/2009_102-eng.php
Date: 2009-06-25
Health Canada is Warning Canadians Not to Use Clean Testing HIV Home Test Kit, or Any Home HIV Test Kit
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2009/2009_97-eng.php
Date: 2009-06-23
Market withdrawal of Raptiva (efalizumab) in Canada - EMD Serono Canada Inc.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/raptiva_3_hpc-cps-eng.php
Date: 2009-06-17
Important Safety Information concerning Kappa 600/700/900 Series and Sigma 100/200/300 Series Implantable Pulse Generators - Medtronic of Canada Ltd.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/kappa_sigma_hpc-cps-eng.php
Date: 2009-06-05
Information on the association of CellCept (mycophenolate mofetil) with a potential risk of pure red cell aplasia (PRCA) - Hoffmann-La Roche Limited
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/cellcept_2_hpc-cps-eng.php
Date: 2009-06-04
APRIL 2009
Association of Herceptin (trastuzumab) with Oligohydramnios - Hoffman-La Roche Limited
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/herceptin_hpc-cps-eng.php
Date: 2009-04-24
Association of Enbrel (etanercept) with Histoplasmosis and Other Invasive Fungal Infections - Amgen Canada Inc.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/enbrel_hpc-cps-eng.php
Date: 2009-04-23
Urgent Device Correction Letter: COLLEAGUE Single Channel and Triple Channel Volumetric Infusion Pumps - Baxter Corporation Canada
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/infusion-perfusion_pump-pompe_7_hpc-cps-eng.php
Date: 2009-04-03
MARCH 2009
Association of Phosphocol P32 (Chromic Phosphate P32) with acute lymphocytic leukemia (ALL) - Tyco Healthcare
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/phosphocol_hpc-cps-eng.php
Date: 2009-03-30
Urgent Medical Device Correction - AED Plus Defibrillator: serial numbers below x - - -200000 - ZOLL Medical Corporation
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/zoll_def_hpc-cps-eng.php
Date: 2009-03-26
Misuse of blood lancing devices
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/blood-capill_lanc-ponc_dev-dis_2_nth-aah-eng.php
Date: 2009-03-24
Drug Release Information for the EVRA Transdermal Contraceptive System - Janssen-Ortho Inc.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/evra_2_hpc-cps-eng.php
Date: 2009-03-19
Safety information regarding topical anesthetics and serious adverse events - AstraZeneca Canada Inc. and Smith & Nephew Inc.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/emla_ametop_hpc-cps-eng.php
Date: 2009-03-05
FEBRUARY 2009
Suspension of marketing of Raptiva (efalizumab) in Canada - EMD Serono Canada Inc.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/raptiva_2_hpc-cps-eng.php
Date: 2009-02-20
New Safety Information Regarding Progressive Multifocal Leukoencephalopathy (PML) Associated with Tysabri (natalizumab) Biogen Idec Canada Inc.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/tysabri_2_hpc-cps-eng.php
Date: 2009-02-18
JANUARY 2009
Additional safety information related to Botox / Botox Cosmetic (botulinum toxin type A) - Allergan Canada
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/botox_hpc-cps-eng.php
Date: 2009-01-13
Health Canada Endorsed Important Safety Information on Dobutamine Hydrochloride Injection 250 mg/20 ml - Teva novopharm
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/dobutamine-hpc-cps-eng.php
Date: 2009-01-12
Important Changes to the Dose Conversion Guidelines for Fentanyl Transdermal Systems - Janssen-Ortho Inc., Cobalt Pharmaceuticals Inc., Novopharm Limited, Ranbaxy Pharmaceuticals Canada Inc. and ratiopharm inc.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/fentanyl_hpc-cps-eng.php
Date: 2009-01-07
Recall of Lot 7101490 of PPC Piperacillin/Tazobactam for Injection, 4.5g/vial - Pharmaceutical Partners of Canada Inc.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/piperacillin-tazobactam_hpc-cps-eng.php
Date: 2009-01-05
December 2008
Association of Raptiva (efalizumab) with serious infections, including progressive multifocal leukoencephalopathy in patients with psoriasis - EMD Serono Canada Inc.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2008/raptiva_hpc-cps-eng.php
Date: 2008-12-30
Reports of Eye Inflammation, Endophthalmitis, and Toxic Anterior Segment Syndrome (TASS) Following Off-label Intravitreal Use of Avastin (bevacizumab) - Hoffmann-La Roche Limited
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2008/avastin_4_hpc-cps-eng.php
Date: 2008-12-19
Health Canada Endorsed Important Safety Information on Tarceva (erlotinib) - Hoffmann-La Roche Limited
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2008/tarceva_hpc-cps-eng.php
Date: 2008-12-17
Possible interference of icodextrin, intravenous immunoglobulins, galactose and d-xylose with certain blood glucose meters
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2008/gluc_met_nth-aah-eng.php
Date: 2008-12-16
Urgent Medical Device Correction: Liko Uno Patient Lift - Hill-Rom
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2008/liko_lift_leve_hpc-cps-eng.php
Date: 2008-12-15
The use of Tarceva (erlotinib) in patients with moderate hepatic impairment and advanced solid tumours
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2008/tarceva_hpc-cps-eng.php
Date: 2008-12-08
November 2008
Infection-related deaths were reported with the use of MabCampath (alemtuzumab) following initial combination therapy with anti-leukemia drugs which also suppress the body's immune response - Bayer HealthCare and Genzyme
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2008/mabcampath_nth-aah-eng.php
Date: 2008-11-21
Important Safety Information on Argatroban - Glaxo Operations UK Limited and Shopper's Drug Mart Specialty Health Network
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2008/argatroban-nth-aah-eng.php
Date: 2008-11-12
October 2008
Safety Information Regarding Overdosage of Venlafaxine HCl Extended-Release Capsules - Wyeth Canada
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2008/venlaflaxine_hpc-cps-eng.php
Date: 2008-10-28
Urgent Medical Device Recall: LifePak CR Plus and LifePak Express Defibrillators - Physio-Control, Incorporated, a division of Medtronic of Canada, Limited
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2008/lifepak_defib_hpc-cps-eng.php
Date: 2008-10-16
Recall Notice for Teleflex Weck Brand Ligating Clips - Teleflex Medical
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2008/ligat_clip_hpc-cps-eng.php
Date: 2008-10-15
Important Safety Information on Tylenol with Codeine in Nursing Mothers and Ultra-Rapid Metabolizers of Codeine Janssen-Ortho Incorporated
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2008/tylenol_codeine_hpc-cps-eng.php
Date: 2008-10-08