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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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The Kraft Heinz Company Voluntarily Recalls Select Varieties of Kraft Singles Products Due to... by FDA Posted in: Blog Posts in Health Education The Kraft Heinz Company is voluntarily recalling select code dates and manufacturing codes of Kraft Singles individually-wrapped slices due to the possibility that a thin st ... Read on »
Unichem Pharmaceuticals (USA), Inc. Issues a Voluntary Nationwide Recall of Hydrochlorothiazide... by FDA Posted in: Blog Posts in Health Education Unichem Pharmaceuticals (USA), Inc. (Unichem) is voluntarily recalling one lot of Hydrochlorothiazide Tablets 25 mg 1000-count bottle to the consumer level. This recall has ... Read on »
Kilwin's Quality Confections, Inc. Issues Allergy Alert on Undeclared Cashew in Sugar Free Milk... by FDA Posted in: Blog Posts in Health Education Kilwin's Quality Confections, Inc., of Petoskey, Michigan, is voluntarily recalling 5 ounce containers of SUGAR FREE Milk Chocolate Caramels because they were incorrectly la ... Read on »
Whole Foods Market Recalls Coconut Curry Cauliflower Salad in Twenty-one Stores Due to Undeclared... by FDA Posted in: Blog Posts in Health Education Whole Foods Market is recalling Coconut Curry Cauliflower Salad sold in twenty-one retail stores in CO, KS, NM, UT, and ID due to undeclared almonds. People who have an all ... Read on »
Allergy Alert On Undeclared Milk In Nutrition Resource Services, Inc.'s Whey, Casein, And... by FDA Posted in: Blog Posts in Health Education NRS - Nutrition Resource Services, Inc. of Bethlehem, PA is voluntarily recalling products with whey concentrate, whey isolate, casein, and colostrum, which contain milk, an ... Read on »
John B. Sanfilippo & Son, Inc. Voluntarily Recalls Fisher Brand 10 Ounce Chopped Walnuts Because... by FDA Posted in: Blog Posts in Health Education John B. Sanfilippo & Son, Inc. (JBSS) announced today that it is voluntarily recalling Fisher brand chopped walnuts packaged in 10 ounce plastic bags because some of these p ... Read on »
Baxter Initiates Voluntary Nationwide Recall of One Lot of IV Solution Due to the Potential For... by FDA Posted in: Blog Posts in Health Education DEERFIELD, Ill., July 30, 2015 - Baxter International Inc. announced today it is voluntarily recalling one lot of intravenous (IV) solution to the hospital/user level due to ... Read on »
Public Workshop FDA/CDC/NLM Workshop on Promoting Semantic Interoperability of Laboratory Data,... by FDA Posted in: Blog Posts in Health Education The purpose of the workshop is to receive and discuss input from stakeholders regarding proposed approaches to promoting the semantic interoperability of laboratory data bet ... Read on »
Posted the July 30, 2015 MDUFA III Quarterly Performance Report by FDA Posted in: Blog Posts in Health Education July 30, 2015 MDUFA III Quarterly Performance Report Read on »
FY 2016 Medical Device User Fee Small Business Qualification and Certification - Guidance for... by FDA Posted in: Blog Posts in Health Education The Medical Device User Fee Amendments (MDUFA) require the payment of a user fee for most types of medical device applications. A business that is qualified and certified a ... Read on »
Cybersecurity Vulnerabilities of Hospira Symbiq Infusion System: FDA Safety Communication by FDA Posted in: Blog Posts in Health Education The FDA is alerting users of the Hospira Symbiq Infusion System to cybersecurity vulnerabilities with this infusion pump. We strongly encourage that health care facilities t ... Read on »
Updated the Topics within CDRH Innovation by FDA Posted in: Blog Posts in Health Education The United States is the global leader in medical device innovation. The Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) is committed ... Read on »
Correction: Letter to 510(k) Holders of Endoscope Devices classified with product code KOG by FDA Posted in: Blog Posts in Health Education This letter is to advise you of a correction to the July 27, 2015 letter you received regarding CDRH’s decision to retire product code KOG. Under the section “What You S ... Read on »
Summary Information for: ReShape Integrated Dual Balloon System by FDA Posted in: Blog Posts in Health Education Labeling, Approval Order, and Summary of Safety and Effectiveness for ReShape Integrated Dual Balloon System (P140012). Read on »
Kroger Recalls Four Seasonings Due to Possible Health Risk by FDA Posted in: Blog Posts in Health Education Cincinnati, Ohio - July 25, 2015 - The Kroger Co. said today it is recalling Kroger Ground Cinnamon, Kroger Garlic Powder, Kroger Coarse Ground Black Pepper and Kroger Bacà ... Read on »
KellBran Candies Issues Allergy Alert on Undeclared Milk in Caramel Popcorn by FDA Posted in: Blog Posts in Health Education KellBran Candies of Akron, Ohio is recalling KellBran Caramel Popcorn, because it contains undeclared milk product. People who have an allergy or severe sensitivity to milk, ... Read on »
Consumer Information on: ReShape Integrated Dual Balloon System - P140012 by FDA Posted in: Blog Posts in Health Education The ReShape Integrated Dual Balloon System (Reshape Dual Balloon) is a weight-loss system of gastric balloons that occupy space in the stomach. The system consists of two at ... Read on »
Teva Parenteral Medicines Initiates Voluntary Nationwide Recall of Select Lots of Adrucil... by FDA Posted in: Blog Posts in Health Education Teva Parenteral Medicines today announced a voluntary recall of six lots of Adrucil® (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) due to the potential presence of pa ... Read on »
Summary Information for: Restylane Lyft with Lidocaine Injectable Gel Injectable Dermal Filler by FDA Posted in: Blog Posts in Health Education Labeling, Approval Order, and Summary of Safety and Effectiveness for Restylane Lyft with Lidocaine Injectable Gel Injectable Dermal Filler (P040024S073). Read on »
Consumer Information on: Restylane Lyft with Lidocaine Injectable Gel Injectable Dermal Filler -... by FDA Posted in: Blog Posts in Health Education Restylane Lyft with Lidocaine is a hyaluronic acid gel that is injected into moderate to severe facial folds and wrinkles. It may also be injected into the check to temporar ... Read on »