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Monthly Archives: August 2012
Automix Automated Nutrition Compounder Systems Class I Recall
Translation Baxter Healthcare Corporation, Automix Automated Nutrition Compounder Systems: Class I Recall – Risk of Fluid Entry into Device Keypads AUDIENCE: Risk Manager, Pharmacy ISSUE: FDA notified healthcare professional of a Class I recall of Baxter Healthcare Automix Automated Nutrition … Continue reading
Posted in FDA 2012, FDA Recall, Pharmacy, Risk Manager
Tagged Automix, Automix Automated Nutrition Compounder Systems, Automix Automated Nutrition Compounder Systems Class I Recall, Baxter Healthcare, Class 1 Recall, Class I Recall, drug risks, FDA recall, Pharmacy, Recall, Risk Manager
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CareFusion 303 Alaris Pump Module Model 8100 Class I Recall
TranslationCareFusion Alaris Pump Module Model 8100: Class I Recall – Motor Stalls During Infusion [Posted 08/24/2012] AUDIENCE: Risk Manager, Biomedical Engineering ISSUE: FDA notified healthcare professionals and their medical care organizations of the Class 1 recall of this product due … Continue reading
Posted in FDA 2012, FDA Recall, Risk Manager
Tagged 303 Alaris Pump Module, CareFusion, CareFusion 303 Alaris Pump Module Model 8100 Class I Recall, Class 1 Recall, Class I Recall, drug risks, FDA recall, Model 8100, Recall
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Reumofan Plus Recall
TranslationReumofan Plus: Recall – Undeclared Drug Ingredient [UPDATED 08/21/2012] FDA is issuing an updated alert that Reumofan Plus and Reumofan Plus Premium contain undeclared active ingredients found in prescription drugs that should be used only under the supervision of a … Continue reading
Posted in Consumer Products, Emergency Rooms, FDA 2012, FDA Recall, Healthcare Professionals
Tagged Consumer, drug risks, Emergency Medicine, FDA recall, Health Professional, natural dietary supplement, Recall, Reumofan Plus, Reumofan Plus Recall
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Synthes Hemostatic Bone Putty Class I Recall
TranslationSynthes Hemostatic Bone Putty: Class I Recall – Potential for Putty to Ignite [Posted 08/21/2012] AUDIENCE: Surgery, Risk Manager ISSUE: There is the potential for Hemostatic Bone Putty to ignite if contacted with electrosurgical cautery systems under certain conditions … Continue reading
Posted in FDA 2012, FDA Recall, Risk Manager, Surgery
Tagged Class 1 Recall, Class I Recall, drug risks, FDA recall, Recall, Risk Manager, Surgery, Synthes Hemostatic Bone Putty, Synthes Hemostatic Bone Putty Class I Recall
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Hospira Propofol Injectable Emulsion Recall
Translation Hospira Propofol Injectable Emulsion: Recall- Glass Vial Defect [Posted 08/16/2012] AUDIENCE: Risk Manager, Pharmacy ISSUE: Hospira and FDA notified healthcare professional of a nationwide recall of three lots of Propofol Injectable Emulsion, 1%, 1g/100 mL, due to visible particles … Continue reading
Posted in FDA 2012, FDA Recall, Pharmacy, Risk Manager
Tagged drug risks, FDA recall, Hospira, Hospira Inc, Hospira Propofol Injectable Emulsion Recall, Injectable Emulsion, Pharmacy, Propofol, Recall, Risk Manager
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St Jude Medical Riata Implantable Cardioverter Defibrillator ICD Leads
Translation St. Jude Medical Riata Implantable Cardioverter Defibrillator (ICD) Leads: Safety Communication – Premature Insulation Failure [Posted 08/16/2012] AUDIENCE: Cardiology, Radiology, Surgery, Family Practice ISSUE: The Food and Drug Administration (FDA) is providing information and recommendations regarding safety concerns with the … Continue reading
Posted in Cardiology, Family Practice, FDA 2012, FDA Notice, Radiology, Surgery
Tagged Cardiology, Cardioverter Defibrillator, drug risks, Family Practice, FDA notice, ICD Leads, Implantable, Radiology, St Jude Medical Riata, St Jude Medical Riata Implantable Cardioverter Defibrillator ICD Leads, Surgery
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Hydromorphone Injection Carpuject Recall
Translation Hospira Hydromorphone Hydrochloride Injection 2 MG/ML, 1 mL fill in 2.5 mL Carpuject: Recall- May Contain More Than The Intended Fill Volume Audience: Risk Manager, Pharmacy Issue: Hospira and FDA notified healthcare professional of a nationwide voluntraty recall … Continue reading
Posted in FDA 2012, FDA Recall, Pharmacy, Risk Manager
Tagged (C-II), 1 mL fill in 2.5 mL, 2 mg/mL, Carpuject by Hospira Inc, drug risks, FDA recall, Hydrochloride Injection, Hydromorphone Injection Carpuject, Hydromorphone Injection Carpuject Recall, Pharmacy, Recall, Risk Manager, USP)
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Covidien Shiley Adult Tracheostomy Tubes Class I Recall
TranslationCovidien Shiley Adult Tracheostomy Tubes: Class I Recall – Reports Of Volume Leakage And/or Disconnection Between The Inner And Outer Cannulae AUDIENCE: Consumer, Health Professional, Home Care ISSUE: FDA notified healthcare professionals that Covidien is recalling certain cuffed Shiley tracheostomy … Continue reading
Posted in Consumer Products, FDA 2012, FDA Recall, Healthcare Professionals, Home Care
Tagged Adult Tracheostomy Tubes, Class 1 Recall, Class I Recall, Consumer, Covidien Shiley, Covidien Shiley Adult Tracheostomy Tubes Class I Recall, drug risks, FDA recall, Health Professional, Home Care, Recall, Shiley tracheostomy tubes
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Codeine Use in Certain Children Drug Risks
TranslationCodeine Use in Certain Children After Tonsillectomy and/or Adenoidectomy: Drug Safety Communication – Risk of Rare, But Life-Threatening Adverse Events or Death AUDIENCE: Pediatricians, Surgery, Consumer ISSUE: The FDA is reviewing reports of children who developed serious adverse effects or … Continue reading
MedWatch July 2012 Safety Labeling Changes
TranslationThe MedWatch July 2012 Safety Labeling Changes posting includes 41 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT. The “Summary Page” provides a listing of drug names and … Continue reading
Posted in FDA 2012, FDA Label Change, FDA Safety Communication
Tagged amlodipine/atorvastatin, anidulafungin, Avinza, AzaSite, azithromycin ophthalmic solution, Biaxin, buprenorphine, Butrans, Caduet, Capsules and Injection, clarithromycin, Dantrium, dantrolene sodium, Diovan, Dolophine, Drug Safety Communication, Duragesic, Embeda, emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg, Eraxis, Exalgo, Extended-Release Capsules, Extended-Release Oral Tablets, Extended-Release Tablets, FDA notice, Fentanyl Transdermal System, for Injection, hydromorphone HCl, July 2012, Kadian, MedWatch, MedWatch July 2012 Safety Labeling Changes, methadone hydrochloride, Methadone hydrochloride Oral Solution and Concentrate, Mirapex, MORPHINE SULFATE, morphine sulfate and naltrexone hydrochloride, Morphine Sulfate Controlled-Release, MS Contin, Natrecor, nesiritide, Nucynta ER, Opana ER, Oral Capsule, oxycodone hydrochloride controlled-release, Oxycontin, oxymorphone hydrochloride, Powder for Injection, pramipexole dihydrochloride, Prograf, safety label changes, Safety Labeling Changes, Sanctura, tablets, Tablets and Diovan HCT, tacrolimus, tapentadol, Transdermal System, trospium chloride, Truvada, valsartan, valsartan/hydrochlorothiazide
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