FDA's Posts - Wellsphere

DIA/FDA CDER/CBER Computational Science Annual Meeting by FDA Posted in: Blog Posts in Health Education Date(s) And Time(s): Mar 22, 2010 8:00AM - Mar 23, 2010 5:00PM Location: Bethesda North Marriott Hotel and Conference Center 57 ... Read on »

Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request;... by FDA Posted in: Blog Posts in Health Education The FDA is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), ... Read on »

FAERS Quarterly Data Files Documentation by FDA Posted in: Blog Posts in Health Education The FDA AERS (FAERS) Program Team is providing information and current thinking about the changes to the FAERS Quarterly Data Extract ... Read on »

Drug Safety Communication: FDA warns about potential medication errors resulting from confusion... by FDA Posted in: Blog Posts in Health Education View and print full Drug Safety Communication (PDF, 43KB) Safety Announcement [5-6-2013] The U.S. Food and Drug Admini ... Read on »

Nestle USA Announces Voluntary Recall of Select Varieties/Production Codes of California Pizza... by FDA Posted in: Blog Posts in Health Education Nestlé USA’s Pizza Division today announced the voluntary recall of select production codes of four different frozen pizzas sold in the U.S. These include: • California Piz ... Read on »

Medtronic Announces FDA Classification Of Deep Brain Stimulation Lead Cap Communication by FDA Posted in: Blog Posts in Health Education In keeping with its commitment to keep physicians informed about product performance and safety, Medtronic, Inc. (NYSE: MDT) issued an Urgent Medical Device Correction notif ... Read on »

Obesity Treatment Devices by FDA Posted in: Blog Posts in Health Education Obesity is a major public health concern in the United States and has been linked to many health problems such as heart disease, stroke, diabetes, high blood pressure, sleep ... Read on »

Meeting Announcement: June 27, 2013 Gastroenterology and Urology Devices Panel of the Medical... by FDA Posted in: Blog Posts in Health Education Meeting Announcement: June 27, 2013 Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Read on »

FDA to Investigate Added Caffeine by FDA Posted in: Blog Posts in Health Education Michael R. Taylor, deputy commissi ... Read on »

American Lifestyle Issues a Worldwide Voluntary Recall of Vicerex Capsules and Black Ant Capsules,... by FDA Posted in: Blog Posts in Health Education May 1, 2013 - American Lifestyle is announcing that it is conducting a voluntary recall of all lots of Vicerex UPC 893490820087 and Black Ant UPC 4026666142546. Laboratory a ... Read on »

American Lifestyle Vicerex and Black Ant Capsules: Recall - Undeclared Drug Ingredient by FDA Posted in: Blog Posts in Health Education AUDIENCE: Consumer ISSUE: May 1, 2013 - American Lifestyle is announcing that it is conducting a voluntary recall of all lots of Vic ... Read on »

Hospira Inc., GemStar Infusion System: Recall - Lithium Battery Low Voltage by FDA Posted in: Blog Posts in Health Education Models 13000, 13100, 13150, 13086, 13087, 13088 UPDATED 05/01/2013. Damage from battery leakage may cause the device to shut off w ... Read on »

Newport Medical Instruments, Inc., HT70 and HT70 Plus Ventilators: Class I Recall - Unit Goes Into... by FDA Posted in: Blog Posts in Health Education [Posted 05/01/2013] AUDIENCE: Risk Manager, Nursing ISSUE: The recall is in response to customer reports of Newport Medical Ins ... Read on »

FDA Drug Safety Communication: FDA limits duration and usage of Samsca (tolvaptan) due to possible... by FDA Posted in: Blog Posts in Health Education View and print full Drug Safety Communication (PDF, 120KB) Safety Announcement [04-30-2013] The U.S. Food and Drug A ... Read on »

Class I Medical Device Recall: Newport Medical Instruments, Inc., HT70 and HT70 Plus Ventilators by FDA Posted in: Blog Posts in Health Education The recall is in response to customer reports of Newport Medical Instrument?s HT70 Ventilator and HT70 Plus Ventilator alarming and going into internal backup battery sooner ... Read on »

Class I Medical Device Recall: Hospira Inc., GemStar Infusion System - Damage from Battery Leakage by FDA Posted in: Blog Posts in Health Education Damage from Battery Leakage May Cause the Device to Shut Off Without Warning. Read on »

Carson’s Deli & Bakery Issues Allergy Alert For Undeclared Allergens In Assorted Cookie Pack... by FDA Posted in: Blog Posts in Health Education CARSON’S DELI & BAKERY of Lockport, NY is recalling 200 packages of ASSORTED COOKIE PACK, UPC 7 53182 15240 0, and FUDGE BROWNIE COOKIES, UPC 7 53182 15240 0 because they co ... Read on »

Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) BLOOD-PACK Unit By Fenwal: Recall -... by FDA Posted in: Blog Posts in Health Education [Posted 04/30/2013] AUDIENCE: Risk Manager, Health Professional, Pharmacy ISSUE: Fenwal initiated a voluntary Urgent Product Re ... Read on »

Samsca (Tolvaptan): Drug Safety Communication - FDA Limits Duration and Usage Due To Possible... by FDA Posted in: Blog Posts in Health Education [Posted 04/30/2013] AUDIENCE: Pharmacy, Health Professional, Patient ISSUE: FDA has determined that the drug Samsca (tolvaptan) ... Read on »

Krinos Foods, LLC. Voluntarily Recalls Tahini Jars Because of Possible Health Risk by FDA Posted in: Blog Posts in Health Education Krinos Foods, LLC. of Long Island City, New York is voluntarily recalling its TAHINI sesame paste, because it has the potential to be contaminated with Salmonella, an organi ... Read on »

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