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Proactive Disclosure
For Health Professionals - 2009
December
- Cerezyme (imiglucerase for injection) - Supply and Recommendations for Restarting Cerezyme - Genzyme Canada Inc.
- Myfortic (mycophenolate sodium) - Reports of Pure Red Cell Aplasia in Patients - Novartis Pharmaceuticals Canada Inc.
- Thyrogen (thyrotropin alfa for injection): Caution with Preparation and Administration - Genzyme
- Cerezyme (imiglucerase for injection), Fabrazyme (agalsidase beta), Myozyme (alglucosidase alfa) and Aldurazyme (laronidase): Caution with Preparation and Administration - Genzyme
- Exjade (deferasirox) - Proposed Changes to the Canadian Product Monograph - Novartis Pharmaceuticals Canada Inc.
- Rapamune (sirolimus) - Blood Level Measurement Changes
November
- Heparin - Decreased Potency as a Result of New United States Pharmacopeia (USP) Standards
- Foreign Particles Found In Certain Products From Genzyme [2009-11-25]
- Authorization for Sale and Post-Market Activities for Arepanrix H1N1 Vaccine - GlaxoSmithKline Inc.
- Association of Relenza (zanamivir) dry powder for inhalation with fatal outcome when administered by nebulization instead of inhalation - GlaxoSmithKline
October
September
- Important Safety Information on Hospira Devices that have Defective AC Power Cords - Hospira Healthcare Corporation
Important Safety Information on PediCap Pediatric End-Tidal CO2 Detectors - Tyco Healthcare Canada
August
July
June
- Updated Labelling for Piroxicam - Drug No Longer to be Used for Acute Pain or Inflammation [2009-06-25]
- Market withdrawal of Raptiva (efalizumab) in Canada - EMD Serono Canada Inc.
- Important Safety Information concerning Kappa 600/700/900 Series and Sigma 100/200/300 Series Implantable Pulse Generators - Medtronic of Canada Ltd.
- Information on the association of CellCept (mycophenolate mofetil) with a potential risk of pure red cell aplasia (PRCA) - Hoffmann-La Roche Limited
May
- Recall of one lot of Dobutamine Hydrochloride Injection 250 mg /20 mL due to labelling error regarding dose - Teva Novopharm
- Recall of one lot of Rofact (rifampin) 300 mg due to labelling error - Valeant Canada Limited
- Important Safety Information - BHM/Medi-Man Combi Sling - Possible Stitching Failure - BHM Medical Inc.
- Association of TARCEVA (erlotinib) with cases of gastrointestinal perforation, Stevens-Johnson syndrome, and corneal perforation - Hoffmann-La Roche Limited
- Important Safety Information Concerning Pre-filled Saline and Heparin Syringes Manufactured by MedXL Inc.
April
- Association of Herceptin (trastuzumab) with Oligohydramnios - Hoffman-La Roche Limited
- Association of Enbrel (etanercept) with Histoplasmosis and Other Invasive Fungal Infections - Amgen Canada Inc.
- Urgent Device Correction Letter: COLLEAGUE Single Channel and Triple Channel Volumetric Infusion Pumps - Baxter Corporation Canada
- Standards for Improved Fire Safety of Mattresses
March
- Association of Phosphocol P32 (Chromic Phosphate P32) with acute lymphocytic leukemia (ALL) - Tyco Healthcare
- Urgent Medical Device Correction - AED Plus Defibrillator: serial numbers below x - - -200000 - ZOLL Medical Corporation
- Misuse of blood lancing devices
- Drug Release Information for the EVRA Transdermal Contraceptive System - Janssen-Ortho Inc.
- Safety information regarding topical anesthetics and serious adverse events - AstraZeneca Canada Inc. and Smith & Nephew Inc.
February
- Suspension of marketing of Raptiva (efalizumab) in Canada - EMD Serono Canada Inc.
- New Safety Information Regarding Progressive Multifocal Leukoencephalopathy (PML) Associated with Tysabri (natalizumab) - Biogen Idec Canada Inc.
January
- Additional safety information related to Botox / Botox Cosmetic (botulinum toxin type A) - Allergan Canada
- Health Canada Endorsed Important Safety Information on Dobutamine Hydrochloride Injection 250 mg/20 ml - Teva novopharm
- 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.
- Recall of Lot 7101490 of PPC Piperacillin/Tazobactam for Injection, 4.5g/vial - Pharmaceutical Partners of Canada Inc.