Category Archives: FDA 2013

Methylphenidate ADHD Medications Drug Safety Communication

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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 XR, Ritalin/Ritalin LA/Ritalin SR AUDIENCE: Psychiatry, Family Medicine, Consumer ISSUE: FDA is warning that methylphenidate products, one type … Continue reading

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Soliris (Eculizumab) Concentrated Solution Alexion Recall

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Soliris (Eculizumab) Concentrated Solution for Intravenous Infusion by Alexion: Recall – Visible Particles AUDIENCE: Hematology, Pharmacy ISSUE: Alexion Pharmaceuticals, Inc. is providing information regarding a previously communicated voluntary recall of two lots of Soliris (eculizumab) Concentrated Solution for Intravenous Infusion. … Continue reading

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November 2013 Safety Labeling Changes

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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 changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and … Continue reading

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HeartStart Automated External Defibrillators AED Philips Healthcare

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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 AUDIENCE: Risk Manager, Emergency Medicine, Health Professional ISSUE: FDA issues safety communication on HeartStart … Continue reading

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Onfi clobazam Drug Safety Communication

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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 cause rare but serious skin reactions that can result in permanent harm … Continue reading

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FreeStyle and FreeStyle Lite Blood Glucose Test Strips by Abbott Recall

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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 recall of 20 lots of FreeStyle and FreeStyle Lite Blood Glucose Test … Continue reading

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Nitroglycerin in 5% Dextrose Injection by Baxter Recall

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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 recall of one lot of Nitroglycerin in 5% Dextrose Injection due to particulate matter … Continue reading

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Spacelabs Anesthesia Workstations and Service Kits Class I Recall

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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 notified healthcare professionals of a Class I Recall due to a potential defect in … Continue reading

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CLR Medicals International Inc Viscoelastic Products Recall

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CLR Medicals International Inc. Viscoelastic Products: Recall – Quality System Deficiencies And Lack Of Premarket Approval (PMR) AUDIENCE: Risk Management, Health Professional ISSUE: CLR Medicals International Inc., initiated a nationwide recall of Viscocel and Viscocel Plus, in response to FDA … Continue reading

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Hospira GemStar Infusion System Class I Recall

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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 distal pressure sensor calibration can drift resulting in the pump failing the Proximal … Continue reading

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