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MedWatch Safety Alert RSS Feed FDA MedWatch Safety Alerts http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/MedWatch/rss.xml en-us Fri, 24 May 2013 11:30:00 -0400 jay.wattenberg@fda.hhs.gov (Jay Wattenberg) FDA MedWatch http://www.fda.gov/ucm/groups/fdagov-public/documents/image/ucm052224.gif http://www.fda.gov/Safety/MedWatch/default.htm 144 52 FDA MedWatch Safety Alerts Cook Medical, Inc Zilver PTX Drug-Eluting Peripheral Stent: Class 1 Recall - Complaints of Delivery System Tip Separation Inner delivery catheter breakage can lead to vascular occlusion, thrombosis, amputation, possible cardiac arrest, or death. Fri, 24 May 2013 11:30:00 -0400 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm353900.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm353900.htm Methotrexate Sodium, USP Injectable Vials by Sandoz US: Recall - Particulate Matter In Vials Particulate matter in parenteral drugs has been recognized as a potential health hazard. Tue, 21 May 2013 06:05:00 -0400 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm353266.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm353266.htm Abbott Diabetes Care: Class 1 Recall - FreeStyle InsuLinx Blood Glucose Meters - Risk of Incorrect Test Result Incorrect test results at extremely high blood glucose levels. Mon, 20 May 2013 14:00:00 -0400 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm353136.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm353136.htm All Sterile Drug Products Made and Distributed By NuVision Pharmacy Dallas Facility: Recall - Lack Of Sterility Assurance If a drug product marketed as sterile has microbial contamination, patient is at risk of serious infection. Sat, 18 May 2013 15:51:00 -0400 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm352949.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm352949.htm Compounded Prescription Therapies By Pentec Health Inc.: Recall - Lack Of Sterility Assurance Patients are at increased risk of infection in the event a sterile product is compromised. Fri, 17 May 2013 15:55:00 -0400 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm352939.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm352939.htm Zolpidem Containing Products: Drug Safety Communication - FDA Requires Lower Recommended Doses UPDATED 05/14/2013. FDA has approved label changes specifying new dosing recommendations for zolpidem products. Tue, 14 May 2013 10:30:00 -0400 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm334738.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm334738.htm Atriphen dietary supplement (Xymogen brand): Recall - Potential Allergic Reaction Due to Milk and Soy Risk of serious or life-threatening allergic reaction. Thu, 09 May 2013 16:00:00 -0400 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm351525.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm351525.htm The Compounding Shop: FDA News Release - Lack of Sterility Assurance of Drug Products These products should not be administered to patients. If a drug product marketed as sterile has microbial contamination, it potentially places patients at risk of serious infection. Wed, 08 May 2013 17:45:00 -0400 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm351326.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm351326.htm SexVoltz, Velextra, and Amerect by Beomonstar Products: Recall - Undeclared Drug Ingredient Undeclared tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Wed, 08 May 2013 09:30:00 -0400 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm351181.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm351181.htm Bullet Proof: Public Notification - Undeclared Drug Ingredient Testing revealed the product contains tadalafil, which may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Tue, 07 May 2013 17:30:00 -0400 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm351157.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm351157.htm Lightning Rod Capsules: Recall - Undeclared Drug Ingredient Testing revealed the product contains an analogue of sildenafil, which may interact with nitrates found in prescription drugs such as nitroglycerin, and lower blood pressure to dangerous levels. Tue, 07 May 2013 17:15:00 -0400 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm351156.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm351156.htm Maquet SERVO-i Ventilator Battery Module: Class 1 Recall - Battery Run Time Shorter Than Expected May result in unexpected ventilator shut downs, which can result in serious adverse health consequences, including death. Tue, 07 May 2013 16:45:00 -0400 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm351146.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm351146.htm Medtronic: Class 1 Recall - Medtronic Deep Brain Stimulation Lead Kit and Activa Dystonia HDE Kit Use of lead cap may cause lead damage. Lead replacement may be required or optimal therapy may not be provided. Tue, 07 May 2013 14:30:00 -0400 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm351094.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm351094.htm Covidien Surgical Stapler Reloads: FDA Safety Communication - Devices Stolen Before They Were Sterilized Use of these non-sterile products could increase the risk of infection in surgical patients. Tue, 07 May 2013 12:15:00 -0400 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm351052.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm351052.htm Cardinal Health: Class 1 Recall - Various Presource Kits Containing a Pre-Assembled Anesthesia Circuit Plastic packaging may become lodged in the filter potentially causing an obstruction in airflow, which may result in low blood oxygen (hypoxia), suffocation and death. Tue, 07 May 2013 10:15:00 -0400 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm351024.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm351024.htm Valproate Anti-Seizure Products: Drug Safety Communication - Contraindicated for Pregnant Women for Prevention of Migraine Headaches Based on a recent study, there is evidence that these medications can cause decreased IQ scores in children whose mothers took them while pregnant. Mon, 06 May 2013 13:20:00 -0400 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm350868.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm350868.htm Kadcyla (ado-trastuzumab emtansine): Drug Safety Communication - Potential Medication Errors Resulting from Name Confusion Use of the incorrect nonproprietary name for Kadcyla in some medication-related electronic systems poses a risk of mix-up with Herceptin (trastuzumab). Mon, 06 May 2013 10:30:00 -0400 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm350817.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm350817.htm American Lifestyle Vicerex and Black Ant Capsules: Recall - Undeclared Drug Ingredient Laboratory analysis has found tadalafil and sildenafil. Thu, 02 May 2013 04:30:00 -0400 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm350616.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm350616.htm Hospira Inc., GemStar Infusion System: Recall - Lithium Battery Low Voltage UPDATED 05/01/2013. Damage from battery leakage may cause the device to shut off without warning. Wed, 01 May 2013 17:03:00 -0400 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm349896.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm349896.htm Newport Medical Instruments, Inc., HT70 and HT70 Plus Ventilators: Class I Recall - Unit Goes Into Internal Backup Battery Sooner Than Expected The screen on the ventilator may indicate that the Power Pac battery is fully charged when it is not, or the unit may switch to backup battery power as soon as it is removed from AC power. Wed, 01 May 2013 16:40:00 -0400 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm350438.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm350438.htm