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Monthly Archives: July 2012
Ampyra dalfampridine drug risks
Translation Drug Safety Communication – Seizure Risk for Multiple Sclerosis Patients AUDIENCE: Neurology, Internal Medicine ISSUE: FDA is updating health care professionals and the public about the risk of seizures in patients with multiple sclerosis (MS) who are starting Ampyra … Continue reading
Posted in FDA 2012, FDA Safety Communication, FDA Warning, Internal Medicine, Neurology
Tagged Ampyra, Ampyra dalfampridine Drug Risks, dalfampridine, drug risks, Drug Safety Communication, FDA warning, Internal Medicine, MS, multiple sclerosis, Neurology, seizures
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CareFusion EnVe Ventilators Class I Recall
TranslationCareFusion EnVe Ventilators: Class I Recall – Leak In Patient Breathing Circuit or System AUDIENCE: Critical Care Medicine, Risk Manager ISSUE: FDA notified healthcare professionals of a Class I Recall of CareFusion EnVe Ventilators manufactured from December, 2010 through … Continue reading
Posted in Critical Care Medicine, FDA 2012, FDA Recall, Risk Manager
Tagged CareFusion EnVe Ventilators, CareFusion EnVe Ventilators Class I Recall, Class 1 Recall, Class I Recall, Critical Care Medicine, FDA recall, Recall, Risk Manager
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Alere Triage Diagnostic Tests Class I Recall
TranslationAlere Triage Diagnostic Tests (Multiple Tests): Class I Recall – Potential for Significantly Decreased Precision Including Triage CardioProfiler Panel, Triage Cardiac Panel, Triage Profiler SOB Panel, Triage BNP, and Triage D-dimer AUDIENCE: Laboratory, Cardiology, Pulmonology, Risk Manager ISSUE: FDA notified … Continue reading
Posted in Cardiology, FDA 2012, FDA Recall, Laboratory, Pulmonology, Risk Manager
Tagged Alere Triage Diagnostic Tests, Alere Triage Diagnostic Tests Class I Recall, Cardiology, Class 1 Recall, Class I Recall, FDA recall, Laboratory, Pulmonology, Recall, Risk Manager
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GE Healthcare Aestiva 5 7900 Ventilator Class 1 Recall
TranslationGE Healthcare Aestiva/5 7900 Ventilator – Class 1 Recall – Potential for Unrecognized Overdose AUDIENCE: Risk Manager ISSUE: FDA notified healthcare professionals of a Class I Recall of the GE Healthcare Aestiva/5 7900 Ventilator. There is a potential for two … Continue reading
June 2012 Safety Labeling Changes
TranslationThe MedWatch June 2012 Safety Labeling Changes posting includes 35 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 1.5% ophthalmic, atomoxetine hydrochloride, Avodart, azithromycin, bepotastine besilate, Bepreve, bismuth subsalicylate, CellCept, darunavir, Drug Safety Communication, dutasteride, dutasteride and tamsulosin HCL, efavirenz, Estraderm, Estradiol, FDA notice, Helidac Therapy, Human 10%, Incivek, Jalyn, June 2012 Safety Labeling Changes, lisinopril, lisinopril/hydrochlorothiazide, Methergine, methylergonovine maleate, metronidazole and tetracycline hydrochloride, mycophenolate mofetil, mycophenolate mofetil hydrochloride, mycophenolic acid, Myfortic, Noxafil, posaconazole, Prezista, Prinivil, Prinzide, Privigen Immune Globulin Intravenous, Safety Communication, safety label changes, solifenacin succinate, Stelara, Strattera, Sustiva, tablets, telaprevir, transdermal, ustekinumab, Vesicare, Zithromax
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iFlora Kids Supplements Recall
TranslationiFlora Kids Multi-Probiotic and iFlora 4-Kids Powder Dietary Supplements: Recall – Possible Salmonella Contamination AUDIENCE: Consumer ISSUE: Sedona Labs today announced that its supplier of Galactooligosaccharide (GOS) has recalled this ingredient due to a possible Salmonella contamination. As a result,Sedona … Continue reading
Posted in Consumer Products, FDA 2012, FDA Recall
Tagged Consumer, Consumer Products, drug risks, FDA recall, iFlora 4-Kids Powder Dietary Supplements, iFlora Kids Multi-Probiotic, Possible Salmonella Contamination, Recall
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CareFusion Airlife Infant Breathing Circuit Class I Recall
TranslationCareFusion Airlife Infant Breathing Circuit: Class I Recall – Potential for Leak in Closed Ventilation System AUDIENCE: Anesthesiology, Risk Manager ISSUE: FDA notified healthcare professionals of the Class 1 recall of the Airlife infant breathing circuit due to the risk … Continue reading
Advanced Sterilization Products ASP Sterrad Cyclesure 24 Biological Indicator Safety Communication
TranslationAdvanced Sterilization Products (ASP) Sterrad Cyclesure 24 Biological Indicator: Safety Communication – Potential Risk of Infection [UPDATED 07/06/2012] The FDA issued a clarification for personnel at facilities that utilize Sterrad sterilizers: The voluntary recall is for only certain lots of … Continue reading
Leucovorin Calcium Injection Bedford Laboratories Recall
TranslationLeucovorin Calcium Injection (Bedford Laboratories): Recall – Visible Particulate Matter AUDIENCE: Pharmacy, Risk Manager, Oncology ISSUE: Bedford Laboratories issued a nationwide recall of three lots of Leucovorin Calcium Injection, due to the discovery of visible crystalline particulate matter in a … Continue reading
Posted in FDA 2012, FDA Recall, Oncology, Pharmacy, Risk Manager
Tagged Bedford Laboratories, drug risks, FDA recall, Leucovorin Calcium Injection, Leucovorin Calcium Injection Bedford Laboratories Recall, Oncology, Pharmacy, Recall, Risk Manager
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Sterrad Cyclesure 24 Biological Indicator Safety Communication
Translation Advanced Sterilization Products (ASP) Sterrad Cyclesure 24 Biological Indicator: Safety Communication – Potential Risk of Infection AUDIENCE: Risk Manager, Surgery, Infectious Disease ISSUE: An FDA review of ASP data showed that the Sterrad Cyclesure 24 Biological Indicators cannot effectively … Continue reading