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Methylphenidate ADHD Medications Drug Safety Communication
Methylphenidate ADHD Medications: Drug Safety Communication – Risk of Long-lasting Erections Including Concerta, Daytrana, Focalin/Focalin XR, Metadate CD/Metadate ER, Methylin/Methylin ER, Quillivant...
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Soliris (Eculizumab) Concentrated Solution Alexion Recall
Soliris (Eculizumab) Concentrated Solution for Intravenous Infusion by Alexion: Recall – Visible Particles AUDIENCE: Hematology, Pharmacy ISSUE: Alexion Pharmaceuticals, Inc. is providing information...
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November 2013 Safety Labeling Changes
November 2013 Safety Labeling Changes includes 27 products with revisions to Prescribing Information The MedWatch November 2013 Safety Labeling Changes posting includes 27 products with safety labeling...
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HeartStart Automated External Defibrillators AED Philips Healthcare
HeartStart Automated External Defibrillators (AED) From Philips Healthcare: Safety Communication – Failure Of An Electrical Component That Could Cause AEDs To Fail To Deliver Appropriate Shock...
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Onfi clobazam Drug Safety Communication
Onfi (clobazam): Drug Safety Communication – Risk of Serious Skin Reactions AUDIENCE: Neurology, Pharmacy, Dermatology ISSUE: FDA is warning the public that the anti-seizure drug Onfi (clobazam) can...
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FreeStyle and FreeStyle Lite Blood Glucose Test Strips by Abbott Recall
FreeStyle and FreeStyle Lite Blood Glucose Test Strips by Abbott: Recall – Erroneously Low Blood Glucose Results AUDIENCE: Consumer, Family Physician, Pharmacy ISSUE: Abbott is initiating a voluntary...
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Nitroglycerin in 5% Dextrose Injection by Baxter Recall
Nitroglycerin in 5% Dextrose Injection by Baxter: Recall – Particulate Matter AUDIENCE: Risk Managers, Critical Care Medicine, Cardiology ISSUE: Baxter International Inc has initiated a voluntary...
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Spacelabs Anesthesia Workstations and Service Kits Class I Recall
Spacelabs Healthcare, Inc., Spacelabs Anesthesia Workstations and Service Kits: Class I Recall – Bag-to-Vent Switch in CAS I/II Absorbers May Fail AUDIENCE: Risk Manager, Anesthesiology ISSUE: FDA...
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CLR Medicals International Inc Viscoelastic Products Recall
CLR Medicals International Inc. Viscoelastic Products: Recall – Quality System Deficiencies And Lack Of Premarket Approval (PMR) AUDIENCE: Risk Management, Health Professional ISSUE: CLR Medicals...
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Hospira GemStar Infusion System Class I Recall
Hospira GemStar Infusion System: Class I Recall – Pressure Sensor Calibration Drift AUDIENCE: Biomedical Engineering, Nursing, Critical Care Medicine, Home Care, Risk Manager ISSUE: The proximal and...
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MedStream Programmable Infusion Pump Codman and Shurtleff Class 1 Recall
MedStream Programmable Infusion Pump and Refill Kits by Codman and Shurtleff: Class 1 Recall – Drug Over Infusion AUDIENCE: Risk Manager, Health care Professional ISSUE: FDA and Codman & Shurtleff,...
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Specialty Medicine Compounding Pharmacy Recall
Specialty Medicine Compounding Pharmacy Certain Unexpired Compounded Sterile Products: Recall – Particulate Matter Found in Vials AUDIENCE: Pharmacy, Patient, Health Professional ISSUE: Specialty...
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Bard LifeStent Solo Vascular Stent Class 1 Recall
Bard LifeStent Solo Vascular Stent: Class 1 Recall – Failure to Deploy AUDIENCE: Cardio-vascular Surgery, Interventional Radiology ISSUE: FDA notified health professionals and medical care...
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Albuterol Sulfate Inhalation Solution Nephron Pharmaceuticals Recall
Albuterol Sulfate Inhalation Solution, 0.083 percent (Nephron Pharmaceuticals): Recall – Aseptic Processing Simulation Results AUDIENCE: Pharmacy ISSUE: Nephron Pharmaceuticals initiated a voluntary...
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St Jude Amplatzer Atrial Septal Occluder ASO Safety Communication
St. Jude Amplatzer Atrial Septal Occluder (ASO): Safety Communication – Reports of Tissue Erosion AUDIENCE: Cardiology, Risk Manager, Patient ISSUE: FDA is alerting health care providers and patients...
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Engström Ventilator Aespire View Aisys And Avance Anesthesia Machines
Engström Ventilator, Aespire View, Aisys, And Avance Anesthesia Machines: Voluntary Field Corrective Action – Potential Safety Issue AUDIENCE: Risk Manager, Anesthesiology, Health Professional ISSUE:...
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Avance Aisys And Avance CS2 Anesthesia Delivery Systems
Avance, Aisys And Avance CS2 Anesthesia Delivery Systems: Voluntary Field Corrective Action – Potential Safety Issue AUDIENCE: Risk Manager, Anesthesiology, Health Professional ISSUE: GE Healthcare has...
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Cefepime For Injection USP And Dextrose Injection USP Recall
Cefepime For Injection, USP And Dextrose Injection, USP By B. Braun Medical Inc.: Recall – Visible Particulate Matter AUDIENCE: Pharmacy, Health Professional, Patient ISSUE: B. Braun Medical Inc. is...
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Inclusig Ponatinib Drug Safety Communication
Inclusig (Ponatinib): Drug Safety Communication – Increased Reports Of Serious Blood Clots In Arteries And Veins AUDIENCE: Health Professional, Oncology ISSUE: FDA is investigating an increasing...
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OxyElite Pro Health Advisory
OxyElite Pro: Health Advisory – Acute Hepatitis Illness Cases Linked To Product Use AUDIENCE: Health Professional, Consumer ISSUE: The FDA, along with the Centers for Disease Control and Prevention...
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