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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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Hospira Announces Voluntary Nationwide Recall Of One Lot Of Dobutamine Injection, USP, 250 MG, 20... by FDA Posted in: Blog Posts in Health Education May 14, 2014 - Hospira, Inc. (NYSE: HSP), on Jan. 10, 2014, issued a nationwide recall to the user level for one lot of Dobutamine Injection, USP, 250 mg, 20 mL, Single-dose ... Read on »
Public Workshop ? Hemostatic Medical Devices for Trauma Use, September 3-4, 2014 by FDA Posted in: Blog Posts in Health Education The Food and Drug Administration (FDA) is announcing a public Workshop entitled: ?Hemostatic Medical Devices for Trauma Use?. The purpose of the workshop is to obtain inform ... Read on »
Federal Register: Oxiplex[supreg]/SP Gel; FzioMed, Incorporated's Petition for Review of the... by FDA Posted in: Blog Posts in Health Education The FDA is announcing a meeting to discuss CDRH's denial of a premarket approval application (PMA) for Oxiplex[supreg]/SP Gel (OXIPLEX) submitted by FzioMed, Inc.--the spons ... Read on »
Meeting Notice: June 10, 2014 Oxiplex[supreg]/SP Gel; FzioMed, Incorporated's Petition for... by FDA Posted in: Blog Posts in Health Education Meeting Notice: June 10, 2014 Oxiplex[supreg]/SP Gel; FzioMed, Incorporated's Petition for Review of the Food and Drug Administration's Denial of Premarket Approval Read on »
Surma Distributors LLC, Issues Alert On Undeclared Sulfites In Haque Brand Golden Raisins by FDA Posted in: Blog Posts in Health Education Surma Distributors LLC., located at 1075 Flushing Ave., Brooklyn, NY 11237, is recalling HAQUE brand Golden Raisins because the product contains undeclared sulfites. Read on »
Domega Ny International Co Ltd Issues Allergy Alert On Undecleared Eggs In Brilliant Cake With... by FDA Posted in: Blog Posts in Health Education recalling BRILLIANT CAKE WITH FILLING MILK (BISCUITS) because it contains undeclared eggs. Consumers who have allergies to eggs run the risk of serious or life-threatening a ... Read on »
FDA permits manufacturers of oral health care benzocaine products to include a methemoglobinemia... by FDA Posted in: Blog Posts in Health Education The U.S. Food and Drug Administration advised the Consumer Healthcare Products Association (CHPA) on May 12, 2014 (PDF - 57KB) , that the agency is permitting m ... Read on »
Domega NY International Co LTD Issues Allergy Alert On Undeclared Peanuts In YF Sesame Flavor... by FDA Posted in: Blog Posts in Health Education DOMEGA NY INTERNATIONAL CO LTD, 47-57 BRIDGEWATER STREET BROOKLYN NY 11222 is recalling YF Sesame Flavor Cracker because it contains undeclared peanuts. People who have alle ... Read on »
Stonyfield Extends Voluntary Recall of YoBaby Peach/Pear Yogurt Cup 6-packs to 271 Additional... by FDA Posted in: Blog Posts in Health Education Organic yogurt maker Stonyfield is extending its voluntary recall of YoBaby Peach/Pear yogurt in 4 oz. 6-pack cups with the code date June 05 2014 (UPC 052159701161). The re ... Read on »
Strong America Limited ISSUES ALLERGY ALERT ON UNDECLARED EGG IN “Golden Smell Hotpot Meat... by FDA Posted in: Blog Posts in Health Education Strong America Limited of Long Island City, New York is recalling its 1 pound package of “Golden Smell Hotpot Meat Ball Medley” food treats because they may contain undeclar ... Read on »
Datascope Corp/MAQUET Issues Worldwide Voluntary Recall of the System 98/98XT, CS100, CS100i and... by FDA Posted in: Blog Posts in Health Education In March 2014, Datascope Corp/MAQUET initiated a voluntary worldwide field correction of certain Intra-Aortic Balloon Pumps (IABPs) sold under the Datascope Corp. System 98/ ... Read on »
Federal Register: Ophthalmic Devices Panel of the Medical Devices Advisory by FDA Posted in: Blog Posts in Health Education This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Read on »
Officer/ Employee List for STN 125478/0, RAGWITEK by FDA Posted in: Blog Posts in Health Education DEPARTMENT OF HEALTH & HUMAN SERVICES                                                     Public Health Service                                              ... Read on »
STE Fromagere Du Livradois Voluntarily Recalls Raclette Cheese and Montboissie Cheese for Possible... by FDA Posted in: Blog Posts in Health Education Ste Fromagere du Livradois of Fournols, France is recalling Haut Livradois brand Raclette and Montboissie cheeses lot#350 because they have the potential to be contaminated ... Read on »
MDA Issues Consumer Advisory for Five Flavors of Lily Bloom’s Kitchen Poparoons Milk... by FDA Posted in: Blog Posts in Health Education The Minnesota Department of Agriculture (MDA) is notifying consumers that Lily Bloom’s Kitchen of Fridley, Minnesota, has issued an allergy alert for undeclared allergens in ... Read on »
FDA Voice Blog: Strong Review Performance Brings Innovative Medical Products to Patients by FDA Posted in: Blog Posts in Health Education FDA's official blog brought to you from FDA's senior leadership and staff stationed at home and abroad - sharing news, background, announcements and other information about ... Read on »
April 2014 510(k) Clearances by FDA Posted in: Blog Posts in Health Education 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD April 2014 Read on »
Alere Initiates Voluntary URGENT PRODUCT RECALL of Alere INRatio 2 PT/INR Professional Test Strips by FDA Posted in: Blog Posts in Health Education WALTHAM, Mass. – Alere Inc. (NYSE:ALR) has initiated a voluntary Class 1 recall in the U.S. of the Alere INRatio2 PT/INR Professional Test Strips (PN 99008G2). This action ... Read on »
Eugene Oregon, Inc. Issues Voluntary Nationwide Recall of African Black Ant, Black Ant, and Mojo... by FDA Posted in: Blog Posts in Health Education Eugene Oregon, Inc. is voluntarily conducting this recall because FDA analysis of these products distributed to a third party revealed that the distributed products containe ... Read on »
Federal Register: Center for Devices and Radiological Health Guidance Development and... by FDA Posted in: Blog Posts in Health Education The FDA is announcing the following public workshop entitled "Center for Devices and Radiological Health Guidance Development and Prioritization Public Workshop." The topics ... Read on »