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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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Baxter Initiates U.S. Voluntary Recall of One Lot of Potassium Chloride Injection Due to Shipping... by FDA Posted in: Blog Posts in Health Education Baxter International Inc. announced today it is voluntarily recalling one lot of Potassium Chloride Injection 10mEq per 100mL, product code 2B0826 to the hospital/pharmacy/n ... Read on »
PMA Final Decisions for July 2014 by FDA Posted in: Blog Posts in Health Education These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for July 2014. Read on »
Gel Spice Company, Inc. Issues A Voluntary Recall Of Fresh Finds Brand Ground Black Pepper, 3.53... by FDA Posted in: Blog Posts in Health Education Gel Spice Company, Inc., of Bayonne, NJ, is issuing a voluntary recall notice for 16,443 cases of Fresh Finds-Ground Black Pepper, 3.53 oz, plastic jars, because it has the ... Read on »
Taylor Farms Pacific, Inc. voluntarily recalls Roma Tomatoes due to potential Salmonella... by FDA Posted in: Blog Posts in Health Education Taylor Farms Pacific, Inc. of Tracy, CA has been notified that specific lots of “Expo Fresh” Roma tomatoes supplied to Taylor Farms Pacific may be contaminated with Salmonel ... Read on »
Playtex Adds Production Lot To Its March 2014 Voluntary Recall Of Certain AC/DC Power Adapters... by FDA Posted in: Blog Posts in Health Education Energizer Personal Care – Playtex Manufacturing, Inc. announced today that, out of an abundance of caution, it is adding an adapter production lot to its voluntary nationwid ... Read on »
Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Class II... by FDA Posted in: Blog Posts in Health Education The FDA is announcing the withdrawal of the draft guidance, dated October 2011, in response to the requirements of the Food and Drug Administration Safety and Innovation Act ... Read on »
Check the CDRH Customer Service Score by FDA Posted in: Blog Posts in Health Education This page provides real time results for CDRH's customer satisfaction survey. Read on »
Federal Register: Cardiovascular Devices; Withdrawal of Proposed Rule of Reclassification of... by FDA Posted in: Blog Posts in Health Education The FDA is withdrawing the proposed rule issued October 17, 2011. In that document, FDA proposed to reclassify the external pacemaker pulse generator (EPPG) devices, a pream ... Read on »
Federal Register: Cardiovascular Devices; Reclassification of External Pacemaker Pulse Generator... by FDA Posted in: Blog Posts in Health Education The FDA is proposing to reclassify the external pacemaker pulse generator (EPPG) devices, a preamendments class III device into class II (special controls), and to amend the ... Read on »
Hospira Issues a Voluntary Nationwide Recall of One Lot of Heparin Sodium, 1,000 USP Heparin... by FDA Posted in: Blog Posts in Health Education LAKE FOREST, Ill., - Hospira, Inc. (NYSE: HSP), announced today it is initiating a voluntary nationwide user-level recall of one lot of Heparin Sodium, 1,000 USP Heparin Uni ... Read on »
Summary Information for: Pleximmune by FDA Posted in: Blog Posts in Health Education Labeling, Approval Order, and Summary of Safety and Effectiveness for Pleximmune (H130004). Read on »
Publix Recalls Private Label Jalapeno Bagels by FDA Posted in: Blog Posts in Health Education Out of an abundance of precaution, the company is issuing a voluntary recall for Publix Jalapeno Bagels, which are sold in either the self-service bins or artisan cases in t ... Read on »
Plum Organics Voluntarily Recalls Little Cremes Organic Rice Milk Snacks Due to Potential Choking... by FDA Posted in: Blog Posts in Health Education Plum Organics is voluntarily recalling its Little Cremes organic rice milk snacks line after it was found that the product has the potential to cause choking. The small, bit ... Read on »
Mars Chocolate North America Issues Allergy Alert Voluntary Recall on Undeclared Peanuts and Eggs... by FDA Posted in: Blog Posts in Health Education Today, Mars Chocolate North America announced a voluntary recall of its TWIX Brand Unwrapped Bites 7 oz. Stand Up Pouch with the code date: 421BA4GA60. Fewer than 25 cases o ... Read on »
Pharmacy Creations Issues Voluntary Recall of Four Product Lots With Limited Distribution in... by FDA Posted in: Blog Posts in Health Education Pharmacy Creations has voluntarily recalled four product lots (see below) following testing results conducted by Front Range, Inc., its former independent testing laboratory ... Read on »
Tullia’s Recalls Sauce Because of Possible Health Risk by FDA Posted in: Blog Posts in Health Education Tullia’s is recalling Italian Meatless Pasta Sauce code 530140. This recall has been initiated because a records review by the Washington State Department of Agriculture re ... Read on »
Summary Information for: XPS System with STEEN Solution Perfusate by FDA Posted in: Blog Posts in Health Education Labeling, Approval Order, and Summary of Safety and Effectiveness for XPS System with STEEN Solution Perfusate (H120003). Read on »
La Orocovena Biscuit Voluntarily Recalls Pound Cake de Queso Due to Undeclared Milk, Soy and Wheat by FDA Posted in: Blog Posts in Health Education Through this means we inform to all La Orocoveña Biscuit clients that we will be conducting a recall of the product Pound Cake de Queso, 2oz. Exp. Dates 08/11/2014 to ... Read on »
Tjs Place recalls Basil Pesto Pasta because of potential health risk by FDA Posted in: Blog Posts in Health Education Tjs Place of Kirkland Washington is voluntarily recalling approx. 20 containers of Basil Pesto Pasta packed in 8 oz plastic tubs because it has the potential to be contamina ... Read on »
Federal Register: Medical Devices; Hematology and Pathology Devices; Classification of Early... by FDA Posted in: Blog Posts in Health Education The FDA is classifying early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen characterization into class II (special control ... Read on »