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The Web site of the US Food and Drug Administration (http://www.fda.gov) The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of six product centers, one research center, and two offices.  FDA is responsible for ... Full Bio
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24 Hour Summary posted for February 27, 2015 General and Plastic Surgery Devices Panel of the... by FDA Posted in: Blog Posts in Health Education 24 Hour Summary posted for February 27, 2015 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Read on »
Ateeco, Inc., Maker of Mrs. T’s Pierogies, Issues Voluntary Regional Product Recall of... by FDA Posted in: Blog Posts in Health Education On February 27, 2015, Mrs. T’s Pierogies, of Shenandoah, PA, announced the voluntary recall of specific lots of its Mozzarella, Tomato & Basil variety of pierogies, due to s ... Read on »
Talenti Gelato & Sorbetto Issues Allergy Alert for Limited Number of Jars of Talenti Gelato &... by FDA Posted in: Blog Posts in Health Education Talenti Gelato & Sorbetto, a Unilever company, is voluntarily recalling a limited number of jars of Talenti Gelato & Sorbetto Sea Salt Caramel Gelato because they may inadve ... Read on »
Heartware International Recalls Certain Older Heartware Clinical Trial Controllers by FDA Posted in: Blog Posts in Health Education HeartWare International, Inc. (Nasdaq: HTWR), is issuing a voluntary Urgent Medical Device Recall in the United States related to older HeartWare Ventricular Assist System C ... Read on »
Consumer Information on: VenaSeal Closure System - P140018 by FDA Posted in: Blog Posts in Health Education The VenaSeal Closure System (VenaSeal System) is intended to permanently treat varicose veins of the legs that cause symptoms by sealing the affected veins that are closest ... Read on »
Federal Register: Medical Device Reporting: Electronic Submission Requirements; Correcting... by FDA Posted in: Blog Posts in Health Education The FDA is amending its regulation regarding postmarket electronic Medical Device Reporting (eMDR) to address the unintentional removal of certain provisions of the Unique D ... Read on »
Class I Medical Device Recall: HeartWare Ventricular Assist System (VAS) ? Electrostatic Discharge... by FDA Posted in: Blog Posts in Health Education A buildup of static may cause a sudden discharge of electricity (electrostatic discharge) in the device. When this happens, data in the motor controller that manages the pum ... Read on »
Heritage Pharmaceuticals Initiates a Nationwide Voluntary Recall of Colistimethate for Injection... by FDA Posted in: Blog Posts in Health Education Eatontown, NJ, Heritage Pharmaceuticals Inc. (Heritage) today announced the voluntary nationwide recall of ten (10) lots of Colistimethate for Injection, USP, 150 mg Single- ... Read on »
Fairway “Like No Other Market” Recalls Fairway Brand Raw Hazelnuts (Filberts) Because... by FDA Posted in: Blog Posts in Health Education Fairway “Like No Other Market” of New York, NY, is recalling Fairway brand Raw Hazelnuts (Filberts), because it has the potential to be contaminated with Salmonella, an orga ... Read on »
Purina Animal Nutrition LLC Recalls One Lot of DuMOR Sheep Formula, 50 lbs. Bags Due to... by FDA Posted in: Blog Posts in Health Education Purina Animal Nutrition LLC has initiated a limited voluntary recall of DuMOR Sheep Formula in Florida due to the potential for a higher-than-acceptable level of copper, whi ... Read on »
Sagent Pharmaceuticals Initiates a Nationwide Voluntary Recall of Atracurium Besylate Injection,... by FDA Posted in: Blog Posts in Health Education Schaumburg, IL,Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of two lots of Atracurium Besylate Injection, USP, 50mg/5mL single-dose vials (ND ... Read on »
FDA Voice blog: Moving Toward a National Medical Device Postmarket Surveillance System by FDA Posted in: Blog Posts in Health Education Despite rigorous premarket evaluation, what really counts is how well a medical device works when it?s used day-to-day by patients, caregivers and clinicians. Beyond clinica ... Read on »
FDA Voice blog: Bacterial Infections Associated with Duodenoscopes: FDA?s Actions to Better... by FDA Posted in: Blog Posts in Health Education Duodenoscopes are flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum). Duodenoscopes are used in ... Read on »
24 Hour Summary posted for Feb. 20, 2015 Orthopaedic and Rehabilitation Devices Panel of the... by FDA Posted in: Blog Posts in Health Education 24 Hour Summary posted for Feb. 20, 2015 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Read on »
Urgent: El Popocatepetl Ind., Inc. issues an allergy alert on Undeclared Milk and Yellow #5 in 8... by FDA Posted in: Blog Posts in Health Education El Popocatepetl Ind., Inc. of Chicago, Illinois is voluntarily recalling El Popocatepetl’s 8 in. Chipotle, Spinach Pesto, and Sun Dried Tomato Wraps because they may contain ... Read on »
WhiteWave Foods Voluntarily Recalls Horizon Cheddar Sandwich Crackers by FDA Posted in: Blog Posts in Health Education WhiteWave Foods is voluntarily recalling 7.5 oz packages of Horizon Cheddar Sandwich Crackers because they may contain undeclared peanuts. People who have an allergy or sens ... Read on »
CON YEAGER SPICE COMPANY'S REVISED VOLUNTARY RECALL FOR GROUND CUMIN AND SEASONING BLENDS... by FDA Posted in: Blog Posts in Health Education FOR IMMEDIATE RELEASE-February 20,2015 -New Castle,PA and Zelienople,PA - Con Yeager Spice Company has previously issued a voluntary recall for multiple sized packages under ... Read on »
Old Home Kitchens Issues Allergy Alert and Voluntary Recall on Undeclared Pecans In "Sock It To Me... by FDA Posted in: Blog Posts in Health Education Old Home Kitchens is voluntarily recalling "Sock It To Me Creme Cake" under the "the Bakery baked with pride" label with a production code of 150301100 thru 150310700 ink je ... Read on »
Hummingbird Wholesale Issues Allergy Alert on Undeclared Milk in Organic Chocolate Hazelnut Butter by FDA Posted in: Blog Posts in Health Education Hummingbird Wholesale in Eugene Oregon is recalling 110 jars of Hummingbird Brand Organic Chocolate Hazelnut Butter that may contain undeclared milk. People who have an alle ... Read on »
Chilean Mushrooms is recalling its Chilean Mushrooms because they contained undeclared sulfites by FDA Posted in: Blog Posts in Health Education Kirsch Mushroom Co. Inc. of 751 Drake Street Bronx NY, is recalling its Chilean Mushrooms that were purchased from Nov 1st2014 to Dec 20th 2014 because they contained undecl ... Read on »