Tres Hermanos Bakery Issues Allergy Alert on Undeclared Milk in Telera and Bolillo Breads - FDA Safety Alerts & Drug Recalls

Tres Hermanos Bakery of Wyoming, MI is recalling its white Telera and Bolillo Mexican salt breads because they may contain undeclared milk. People who have allergies to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

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FDA authorizes first test to aid in detecting a type of herpes virus in newborns called cytomegalovirus - FDA Press Releases

FDA authorizes first test to aid in detecting a type of herpes virus in newborns called cytomegalovirus

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Fluorescence assay to predict activity of the glycopeptide antibiotics - Journal of Antibiotics

Fluorescence assay to predict activity of the glycopeptide antibiotics

Fluorescence assay to predict activity of the glycopeptide antibiotics, Published online: 30 November 2018; doi:10.1038/s41429-018-0120-5

Fluorescence assay to predict activity of the glycopeptide antibiotics

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Gemini Food Corporation Conducts Voluntary Recall of Imperial Taste Fried Red Onions and Fired Garlic Due to Undeclared Wheat - FDA Safety Alerts & Drug Recalls

Gemini Food Corporation has voluntarily recalled all Imperial Taste Fried Red Onions & Fried Garlic canisters as a precautionary measure because it’s missing an allergen statement and the ingredient panel does not include wheat.

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ELM Pet Foods Recall of Dry Dog Food Due to Elevated Levels of Vitamin D - FDA Safety Alerts & Drug Recalls

ELM Pet Foods, Inc is issuing a voluntary recall of Elm Chicken and Chickpea Recipe dog food because the products could contain elevated levels of Vitamin D.

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FDA warns company for selling e-liquids that resemble kid-friendly foods as part of the agency’s ongoing Youth Tobacco Prevention Plan - FDA Press Releases

FDA issued a warning letter to Electric Lotus LLC for selling nicotine-containing e-liquids used in e-cigarettes with labeling and/or advertising that cause them to resemble kid-friendly food products.

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FDA approves first treatment for Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder - FDA Press Releases

FDA approved Firdapse (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. LEMS is a rare autoimmune disorder. This is the first FDA approval of a treatment for LEMS.

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ANF Pet Inc. Issues Voluntary Precautionary Recall of Dry Dog Food Due to Potentially Elevated Levels of Vitamin D - FDA Safety Alerts & Drug Recalls

ANF, Inc. is issuing a voluntary recall of select products of ANF Pet Lamb and Rice Dog Food (reference below) due to potentially elevated levels of Vitamin D.

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Sprout Creek Farm Recalls “Kinkead” Cheese due to Possible Health Risk - FDA Safety Alerts & Drug Recalls

Sprout Creek Farm of Poughkeepsie, New York is recalling 4 wheels of “Kinkead” cheese made on 5-10-18, because it has the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

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FDA approves treatment for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a certain genetic mutation - FDA Press Releases

The FDA approved Xospata (gilteritinib) tablets for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.

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FDA approves first biosimilar for treatment of adult patients with non-Hodgkin’s lymphoma - FDA Press Releases

The FDA approved Truxima (rituximab-abbs) as the first biosimilar to Rituxan (rituximab) for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combination with chemotherapy.

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Synthesis and antimicrobial activity of 3,4-bis(arylthio)maleimides - Journal of Antibiotics

Synthesis and antimicrobial activity of 3,4-bis(arylthio)maleimides

Synthesis and antimicrobial activity of 3,4-bis(arylthio)maleimides, Published online: 28 November 2018; doi:10.1038/s41429-018-0122-3

Synthesis and antimicrobial activity of 3,4-bis(arylthio)maleimides

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Allergen Alert: Kitchen Cravings Strawberry and Mixed Berry Parfaits with Trace Tree Nuts - FDA Safety Alerts & Drug Recalls

Kwik Trip, Inc. located in La Crosse, WI is recalling Kitchen Cravings Strawberry and Mixed Berry Parfaits in an 8.25 oz. cup because they may contain undeclared traces of cashews or almonds

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Achdut Recalls Multiple Brands of "Tahini" Because It May Be Contaminated with Salmonella - FDA Safety Alerts & Drug Recalls

Achdut LTD. of Ariel, Israel, is recalling its Tahini products of all packages and sizes produced on the following dates: April 7th to May 21st 2018, because it may be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on how modern predicates can promote innovation and advance safety and effectiveness of medical devices that use 510(k) pathway - FDA Press Releases

FDA Commissioner statement on modernizing the 510(k) pathway by creating policies that rely on newer predicates with modern characteristics related to their safety and performance

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Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of All Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets That Are Within Expiry - FDA Safety Alerts & Drug Recalls

Teva Pharmaceuticals has initiated a voluntary recall in the United States, to the patient level, of all lots of Amlodipine / Valsartan combination tablets and Amlodipine / Valsartan / Hydrochlorothiazide combination tablets (see table below) due to an impurity detected above specification limits in an active pharmaceutical ingredient (API) manufactured by Mylan India. The impurity found in Mylan’s valsartan API is known as N-nitroso-diethylamine (NDEA), which has been classified as a probable human carcinogen. This chemical is typically found in very small amounts in certain foods, drinking water, air pollution, and certain industrial processes.

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Sunshine Mills, Inc. Issues Voluntary Recall of Dry Dog Food Due to Potentially Elevated Levels of Vitamin D - FDA Safety Alerts & Drug Recalls

Sunshine Mills, Inc. is issuing a voluntary recall of select products of Evolve Puppy, Sportsman’s Pride Large Breed Puppy and Triumph Chicken and Rice Dog Food (reference below) due to potentially elevated levels of Vitamin D.

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Statement by FDA Commissioner Scott Gottlieb, M.D., on risk of heavy metals, including nickel and lead, found in some kratom products - FDA Press Releases

FDA scientists tested 26 separate kratom products and found lead and nickel at levels not considered safe for human consumption

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FDA warns consumers to avoid Rhino male enhancement products found at retailers because of undeclared and potentially dangerous drug ingredients - FDA Press Releases

FDA issues a warning to consumers to beware of and avoid certain male enhancement products that may be dangerous to their health

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Identification, molecular characterization, and structural analysis of the blaNDM-1 gene/enzyme from NDM-1-producing Klebsiella pneumoniae isolates - Journal of Antibiotics

Identification, molecular characterization, and structural analysis of the bla_NDM-1 gene/enzyme from NDM-1-producing Klebsiella pneumoniae isolates

Identification, molecular characterization, and structural analysis of the <i>bla</i>_NDM-1 gene/enzyme from NDM-1-producing <i>Klebsiella pneumoniae</i> isolates, Published online: 27 November 2018; doi:10.1038/s41429-018-0126-z

Identification, molecular characterization, and structural analysis of the bla_NDM-1 gene/enzyme from NDM-1-producing Klebsiella pneumoniae isolates

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Geninthiocins C and D from Streptomyces as 35-membered macrocyclic thiopeptides with modified tail moiety - Journal of Antibiotics

Geninthiocins C and D from Streptomyces as 35-membered macrocyclic thiopeptides with modified tail moiety

Geninthiocins C and D from <i>Streptomyces</i> as 35-membered macrocyclic thiopeptides with modified tail moiety, Published online: 27 November 2018; doi:10.1038/s41429-018-0127-y

Geninthiocins C and D from Streptomyces as 35-membered macrocyclic thiopeptides with modified tail moiety

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Emergence and spread of resistant N. meningitidis implicated in invasive meningococcal diseases during the past decade (2008–2017) - Journal of Antibiotics

Emergence and spread of resistant N. meningitidis implicated in invasive meningococcal diseases during the past decade (2008–2017)

Emergence and spread of resistant <i>N. meningitidis</i> implicated in invasive meningococcal diseases during the past decade (2008–2017), Published online: 27 November 2018; doi:10.1038/s41429-018-0125-0

Emergence and spread of resistant N. meningitidis implicated in invasive meningococcal diseases during the past decade (2008–2017)

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Statement from FDA Commissioner Scott Gottlieb, M.D., on the current romaine lettuce E. coli O157:H7 outbreak investigation - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., on the current romaine lettuce E. coli O157:H7 outbreak investigation

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Acknowledgments - Journal of Antibiotics

Acknowledgments

Acknowledgments, Published online: 27 November 2018; doi:10.1038/s41429-018-0108-1

Acknowledgments

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FDA approves an oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumor - FDA Press Releases

The FDA granted accelerated approval to Vitrakvi (larotrectinib), a treatment for adult and pediatric patients whose cancers have a specific genetic feature (biomarker).

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Pfizer Inc. Issues A Voluntary Nationwide Consumer Level Recall of Six Lots of Thermacare® Heatwraps Due to Leaking Wraps With The Potential For Skin Injuries - FDA Safety Alerts & Drug Recalls

Pfizer Consumer Healthcare, a division of Pfizer Inc., is voluntarily recalling six lots of ThermaCare® HeatWrap product to the consumer level. Pfizer Consumer Healthcare initiated this recall because product from these lots has a potential to leak ingredients that are contained in the heat cell wrap.

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Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on transformative new steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of medical devices - FDA Press Releases

FDA provides updates on two elements in medical device safety action plan: modernizing 510(k) program and new process for establishing special controls.

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Ottogi America, Inc. Issues Allergy Alert on Undeclared Egg in Product - FDA Safety Alerts & Drug Recalls

Ottogi America, Inc. of Gardena, California announced today it is recalling 1lb 5.16ounce of Jin Ramen Mild 5pk. (Best Before Aug. 19th 2019) and Jin Ramen Spicy 5pk. (Best Before Aug. 20th 2019) due to undeclared egg as an ingredient on the packages. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume these products.

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FDA Classifies Field Action Related to Fc 500™ And Epics® As Class 1 Recall Beckman Coulter Life Sciences Committed to Helping Customers Take Prompt, Appropriate Actions - FDA Safety Alerts & Drug Recalls

Beckman Coulter Life Sciences today announced the previously communicated global voluntary recall launched in January 2018 related to the FC 500™ Series Flow Cytometers (FC 500), COULTER® EPICS® XL™ and COULTER® EPICS® XL-MCL™ Flow Cytometer with System II Software (together referred to as the EPICS) has been classified as Class 1 by the U.S. Food and Drug Administration (FDA).

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Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex - FDA Safety Alerts & Drug Recalls

Fresenius Kabi USA is voluntarily recalling 163 lots of Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial to the user level. The product insert states that stoppers for both the 10mL and the 20mL vials do not contain natural rubber latex; the tray label for the two vial sizes and the vial label for the 20mL vial also state that the stoppers do not contain latex. The product is being recalled because the stoppers contain natural rubber latex.

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FDA approves new treatment for patients with acute myeloid leukemia - FDA Press Releases

The FDA approved Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are 75 years of age or older or who have other chronic health conditions or diseases (comorbidities) that may preclude the use of intensive chemotherapy.

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Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient - FDA Safety Alerts & Drug Recalls

Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength. These products are being recalled due to detected trace amounts of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Valsartan, USP, manufactured by Mylan Laboratories Limited. NDEA is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen according to the International Agency for Research on Cancer (IARC).

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First Source Issues Allergy Alert on Undeclared Pecan and Cashew in Chocolate and Nut Tray - FDA Safety Alerts & Drug Recalls

First Source of Tonawanda, NY, is voluntarily recalling Chocolate and Nut Tray because it contains undeclared tree nuts, pecan and cashew. People who have an allergy or sensitivity to tree nuts (Pecan & Cashew) run the risk of serious or life-threatening allergic reaction if they consume this product.

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FDA warns marketers of products labeled as dietary supplements that contain tianeptine for making unproven claims to treat serious conditions, including opioid use disorder - FDA Press Releases

FDA issued warning letters issued to two companies for the illegal marketing of products labeled as dietary supplements that contain tianeptine.

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Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on FDA’s updates to Medical Device Safety Action Plan to enhance post-market safety - FDA Press Releases

FDA provides updates on medical device safety action plan describing recent actions we’ve taken to enhance device safety including implementation of NEST and registries on women’s health.

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FDA approves first treatment specifically for patients with rare and life-threatening type of immune disease - FDA Press Releases

The FDA approved Gamifant (emapalumab) for the treatment of pediatric (newborn and above) and adult patients with primary hemophagocytic lymphohistiocytosis (HLH) who have refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. This FDA approval is the first for a drug specifically for HLH.

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Optically active iodohelicene derivatives exhibit histamine N-methyl transferase inhibitory activity - Journal of Antibiotics

Optically active iodohelicene derivatives exhibit histamine N-methyl transferase inhibitory activity

Optically active iodohelicene derivatives exhibit histamine <i>N</i>-methyl transferase inhibitory activity, Published online: 20 November 2018; doi:10.1038/s41429-018-0118-z

Optically active iodohelicene derivatives exhibit histamine N-methyl transferase inhibitory activity

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Statement from FDA Commissioner Scott Gottlieb, M.D., on a new qualified health claim for consuming oils with high levels of oleic acid to reduce coronary heart disease risk - FDA Press Releases

FDA issues a qualified health claim for oleic acid oils based on data showing it reduces cholesterols levels.

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Jay Robb Enterprises Issues Allergy Alert on Undeclared Milk Allergen in Unflavored Egg White Protein - FDA Safety Alerts & Drug Recalls

Jay Robb Enterprises is recalling Jay Robb Unflavored Egg White Protein Product, manufactured by Agropur MSI, LLC of La Crosse, Wisconsin, because it may contain undeclared milk allergen. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

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Declaración del Dr. Scott Gottlieb, comisionado de la FDA, sobre las nuevas medidas propuestas para proteger a los jóvenes impidiendo el acceso a los productos de tabaco de sabores y prohibiendo el uso del mentol en los cigarrillos - FDA Press Releases

El día de hoy, procuro adoptar medidas encaminadas a enfrentar la preocupante tendencia del consumo de nicotina entre los jóvenes y a continuar impulsando las reducciones históricas alcanzadas en los últimos años en las tasas de consumo de cigarrillos combustibles entre los niños.

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Paradoxical growth effect of caspofungin on Candida spp. sessile cells not only at high drug concentrations - Journal of Antibiotics

Paradoxical growth effect of caspofungin on Candida spp. sessile cells not only at high drug concentrations

Paradoxical growth effect of caspofungin on <i>Candida</i> spp. sessile cells not only at high drug concentrations, Published online: 19 November 2018; doi:10.1038/s41429-018-0123-2

Paradoxical growth effect of caspofungin on Candida spp. sessile cells not only at high drug concentrations

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Azolylthioacetamides as potential inhibitors of New Delhi metallo-β-lactamase-1 (NDM-1) - Journal of Antibiotics

Azolylthioacetamides as potential inhibitors of New Delhi metallo-β-lactamase-1 (NDM-1)

Azolylthioacetamides as potential inhibitors of New Delhi metallo-β-lactamase-1 (NDM-1), Published online: 19 November 2018; doi:10.1038/s41429-018-0121-4

Azolylthioacetamides as potential inhibitors of New Delhi metallo-β-lactamase-1 (NDM-1)

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Roche Diagnostics to Replace CoaguChek® XS PT Test Strips - FDA Safety Alerts & Drug Recalls

Roche Diagnostics will be proactively replacing all CoaguChek XS PT Test Strips in the United States.

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The Quaker Oats Company Issues Voluntary Recall of a Small Quantity of Cap’n Crunch’s Peanut Butter Crunch Cereal Distributed to Five Target Stores Due to Possible Health Risk - FDA Safety Alerts & Drug Recalls

The Quaker Oats Company, a subsidiary of PepsiCo, Inc., today announced a voluntary recall of a small quantity of Cap’n Crunch’s Peanut Butter Crunch cereal due to the potential presence of Salmonella. While the potentially affected product only reached five specific Target stores and is limited to 21 boxes of one variety with two Best Before Dates, Quaker is initiating the voluntary recall to protect public health.

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Chukar Cherries Issues Allergy Alert on Undeclared Milk in 7.5 Oz Amaretto Rainier Chocolate Cherries Pouches - FDA Safety Alerts & Drug Recalls

Chukar Cherries of Prosser, WA is recalling 7.5oz Amaretto Rainier Chocolate Cherries because they may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product.

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Recall of Green Cedar Dairy Ackawi Cheese Bearing a Sell by Date of March 26, 2019 or Later - FDA Safety Alerts & Drug Recalls

Routine samples of the Green Cedar Ackawi cheese collected and tested by the U.S. Food and Drug Administration and the Michigan Department of Agriculture and Rural Development tested positive for the presence of Listeria monocytogenes.

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FDA approves new drug to treat travelers’ diarrhea - FDA Press Releases

FDA approved Aemcolo (rifamycin), an antibacterial drug indicated for the treatment of adult patients with travelers’ diarrhea caused by noninvasive strains of Escherichia coli (E. coli), not complicated by fever or blood in the stool.

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Statement from USDA Secretary Perdue and FDA Commissioner Gottlieb on the regulation of cell-cultured food products from cell lines of livestock and poultry - FDA Press Releases

The U.S. Department of Agriculture and U.S. Food and Drug Administration are announcing that USDA and FDA should jointly oversee the production of cell-cultured food products derived from livestock and poultry.

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Statement by FDA Commissioner Scott Gottlieb, M.D., on the FDA’s efforts to hold industry accountable for fulfilling critical post-marketing studies of the benefits, safety of new drugs - FDA Press Releases

The FDA is committed to making sure post-market studies are transparent to the public and that industry is fulfilling their PMRs and PMCs.

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Statement by FDA Commissioner Scott Gottlieb, M.D., on efforts to reduce animal testing through a study aimed at eliminating the use of dogs in certain trials - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to reduce use of animals through a study aimed at eliminating the use of dogs in certain trials

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FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot - FDA Press Releases

The FDA expanded the approved use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL). This is the first FDA approval for treatment of newly diagnosed PTCL, and the agency used a new review program to complete the approval more quickly.

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Results from 2018 National Youth Tobacco Survey show dramatic increase in e-cigarette use among youth over past year - FDA Press Releases

New findings from the National Youth Tobacco Survey show that more than 3.6 million middle and high school students were current (past 30 day) e-cigarette users in 2018.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on proposed new steps to protect youth by preventing access to flavored tobacco products and banning menthol in cigarettes - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., on proposed new steps to protect youth by preventing access to flavored tobacco products and banning menthol in cigarettes

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Nor Cal Food Solutions, LLC ISSUES ALLERGY ALERT ON UNDECLARED Tree Nut – Walnut in The Purveyors Kitchen - Pumpkin Pesto Tapenade - FDA Safety Alerts & Drug Recalls

Nor Cal Food Solutions, LLC of Auburn, CA is announcing a recall of 567 cases of Pumpkin Pesto Tapenade, manufactured by Purveyors Kitchen, because it contains an undeclared tree nut (walnut). People who have an allergy or severe sensitivity to tree nuts (walnuts) run the risk of serious or life-threatening allergic reaction if they consume this product.

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FDA alerts doctors, patients about risk of complications when certain implanted pumps are used to deliver pain medications not approved for use with the devices - FDA Press Releases

FDA alerted health care providers and patients about the serious complications that can occur when using medications not approved for use with implanted pumps that deliver medication into the spinal fluid to treat or manage pain.

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The Pictsweet Company Recalls 8-ounce Steam’ables Asparagus Spears due to Potential for Listeria Monocytogenes - FDA Safety Alerts & Drug Recalls

The Pictsweet Company has recalled 1,872 cases of Pictsweet Farms 8-ounce Steam’ables Asparagus Spears because they have the potential to be contaminated with Listeria monocytogenes.

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Oscor Inc. Issues Recall Product Expansion of TB – Temporary Bipolar Pacing Lead (Unshrouded 2 mm Pins Models) - FDA Safety Alerts & Drug Recalls

On September 26, 2018 Oscor notified customers of a recall for certain lots (Recall No. 1035166- 09/07/2018-01-R) of TB Unshrouded Bipolar Pacing Leads. As part of the recall correction activities, Oscor is retrieving any remaining inventory out in the field. The recall scope is being expanded to include expired inventory for devices distributed between December 21, 2011 to May 17, 2018. The recall expansion is to ensure proper disposition of expired units. The FDA has been notified and is aware Oscor Inc. is voluntarily taking this action.

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FDA warns StemGenex Biologic Laboratories LLC of illegally marketing an unapproved cellular product manufactured in a facility with significant manufacturing violations, putting patients at risk - FDA Press Releases

FDA warns StemGenex Biologic Laboratories LLC of illegally marketing an unapproved cellular product manufactured in a facility with significant manufacturing violations, putting patients at risk

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Alebrije Dist Wholesale Recalls Quesillo Queseria “La Milagrosa” and “Alebrije Cheese” Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

ALEBRIJE DIST WHOLESALE is collaborating with health officials due to a positive finding of Salmonella in a sample of Quesillo “Queseria La Milagrosa”. ALEBRIJE DIST WHOLESALE is voluntarily recalling the amount of 100 kilos of Quesillo “Queseria La Milagrosa”. While “Alebrije Cheese” has not been found positive for Salmonella, ALEBRIJE DIST WHOLESALE has decided to voluntarily recall the specific 498 “Alebrije Cheese” pieces that were imported during the same period out of an abundance of caution.

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Recall of Bittersweet & Feve Chocolate Bars Due to High Levels of Milk Allergens - FDA Safety Alerts & Drug Recalls

Today, Recchiuti Confections (San Francisco, CA) discovered two batches of their Bittersweet Chocolate Bar and two batches of their Feve Chocolate Bar contain high levels of milk protein after FDA sampling. No illnesses have been reported to date. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products. The chocolate bars can be enjoyed if you do not have milk allergies or sensitivities. Recchiuti Confections is issuing an immediate recall for bars with the following lot codes and best buy dates:

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FDA seizes food and medical products held under insanitary conditions at an Arkansas grocery warehouse - FDA Press Releases

U.S. Marshals Service has conducted a mass seizure of FDA-regulated products that were being held in an Arkansas grocery warehouse under insanitary conditions

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In Association With Sunshine Mills, Lidl Voluntarily Recalls Orlando Brand Grain Free Chicken & Chickpea Superfood Recipe Dog Food Due to Elevated Levels of Vitamin D. - FDA Safety Alerts & Drug Recalls

In association with Sunshine Mills, Lidl is voluntarily recalling specific lots of Orlando brand Grain Free Chicken & Chickpea Superfood Recipe Dog Food because the products may contain elevated levels of Vitamin D.

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Natural Life Pet Products Expands Recall of Dry Food Due to Elevated Levels of Vitamin D - FDA Safety Alerts & Drug Recalls

We regret to inform you that Natural Life® Chicken & Potato dry dog food has been confirmed to contain elevated levels of Vitamin D.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen and modernize agency’s oversight and reporting of inspections for sterile injectable drugs - FDA Press Releases

FDA is taking steps to modernize the agency’s inspections program

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FDA authorizes emergency use of first Ebola fingerstick test with portable reader - FDA Press Releases

FDA authorizes emergency use of first Ebola fingerstick test with portable reader

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Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API) - FDA Safety Alerts & Drug Recalls

Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level. This product is being recalled due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Losartan, USP manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz Inc. Losartan Potassium Hydrochlorothiazide product is manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia. This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC).

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Antimicrobial agent isolated from Coptidis rhizome extract incubated with Rhodococcus sp. strain BD7100 - Journal of Antibiotics

Antimicrobial agent isolated from Coptidis rhizome extract incubated with Rhodococcus sp. strain BD7100

Antimicrobial agent isolated from <i>Coptidis rhizome</i> extract incubated with <i>Rhodococcus</i> sp. strain BD7100, Published online: 09 November 2018; doi:10.1038/s41429-018-0114-3

Antimicrobial agent isolated from Coptidis rhizome extract incubated with Rhodococcus sp. strain BD7100

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Baked Potatoes with Cheddar Cheese and Bacon (2 Count) Mis-Labeled as Herb Roasted Potatoes - FDA Safety Alerts & Drug Recalls

Ukrop’s Homestyle Foods is voluntarily recalling Baked Potatoes with Cheddar Cheese and Bacon (2 count), as the product is mislabeled Herb Roasted Potatoes (see photo attached).

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Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to strengthen FDA’s expanded access program - FDA Press Releases

The FDA is committed to the expanded access program which provides a pathway for patients to gain access to investigational drugs, biologics and medical devices for serious diseases and life-threatening conditions outside of clinical trials when no comparable or satisfactory approved alternative therapy options are available.

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Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research, on approval of OTC Primatene Mist to treat mild asthma - FDA Press Releases

FDA approves new version of OTC Primatene Mist inhaler to treat mild, intermittent asthma for people who have been diagnosed with asthma by their physician

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Wegmans Food Markets, Inc. Issues Allergy Alert on Undeclared Milk in Wegmans Pumpkin Loaf, 11 oz., and Wegmans Placek Coffee Cake, 11 oz. and 22 oz. - FDA Safety Alerts & Drug Recalls

Wegmans has initiated a voluntary recall of the following products because they may contain milk not declared on the label. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product.

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Kadesh Incorporation Issues Voluntary Nationwide Recall of Puriton Eye Relief Drops Due to Non-Sterile Production Conditions - FDA Safety Alerts & Drug Recalls

Kadesh, Inc. of Garden Grove, CA is voluntarily recalling all lots of Puriton Eye Relief Drops, 0.5 oz. (15ml) bottle, UPC 7 36972 1679 0, to the consumer level. During a recent FDA inspection, investigators observed that ophthalmic drugs, which are required to be sterile, are manufactured without necessary production controls and conditions to assure sterility.

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Sprout Creek Farm Recalls "Margie" Cheese Due to Listeria Monocytogenes - FDA Safety Alerts & Drug Recalls

Sprout Creek Farm of Poughkeepsie, New York is recalling 132 wheels of "Margie" cheese, because it has the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

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Duncan Hines Classic White, Classic Butter Golden, Signature Confetti and Classic Yellow Cake Mixes Recalled Due to Potential Presence of Salmonella - FDA Safety Alerts & Drug Recalls

Conagra Brands is collaborating with health officials in connection with a positive finding of Salmonella in a retail sample of Duncan Hines Classic White cake mix that may be linked to a Salmonella outbreak that is currently being investigated by CDC and FDA. While it has not been definitively concluded that this product is linked to the outbreak and the investigation is still ongoing, Conagra has decided to voluntarily recall the specific Duncan Hines variety identified (Classic White) and three other varieties (Classic Butter Golden, Signature Confetti and Classic Yellow) made during the same time period out of an abundance of caution.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s effort to make more robust use of mandatory recall authority to quickly remove unsafe foods from the market - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s effort to make more robust use of mandatory recall authority to quickly remove unsafe foods from the market

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Nutrisca Issues Recall of Dry Dog Food Due to Elevated Levels of Vitamin D - FDA Safety Alerts & Drug Recalls

Nutrisca, of Saint Louis, Missouri is voluntarily recalling one formula of Nutrisca dry dog food (described below) due to it containing elevated levels of vitamin D.

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Natural Life Pet Products Issues Recall of Dry Food Due to Elevated Levels of Vitamin D - FDA Safety Alerts & Drug Recalls

Natural Life Pet Products of Saint Louis, Missouri is voluntarily recalling our Chicken & Potato dry dog food (described below) due to it containing elevated levels of Vitamin D.

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Janssen Issues Voluntary Nationwide Recall for one lot of ORTHO-NOVUM 1/35 and two lots of ORTHO-NOVUM 7/7/7 Due to Incorrect Veridate Dispenser Instructions - FDA Safety Alerts & Drug Recalls

Janssen Pharmaceuticals, Inc. has initiated a voluntary recall of one lot of ORTHO-NOVUM 1/35 (norethindrone / ethinyl estradiol) Tablets and two lots of ORTHO-NOVUM 7/7/7 (norethindrone / ethinyl estradiol) Tablets to the pharmacy level. The patient information provided inside affected packages of ORTHO-NOVUM does not include the appropriate instructions for the Veridate dispenser.

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Frito-Lay Issues Allergy Alert on Undeclared Milk In Select Smartfood Delight Sea Salt Flavored Popcorn - FDA Safety Alerts & Drug Recalls

Frito-Lay announced a voluntary recall of select 1/2 oz. bags of Smartfood Delight Sea Salt Flavored popcorn because they were inadvertently filled with cheese flavored tortilla chips that contain undeclared milk ingredients. The recalled bags were sold only in the two variety packs listed below.

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Barcelona Nut Company Recalls Roasted and Salted in Shell Pistachios Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Barcelona Nut Company of Baltimore, Maryland is recalling 239 cases of roasted and salted in shell pistachios, because it has the potential to be contaminated with Salmonella, an organism that can cause serious and sometimes-fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.

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FDA permits marketing of two devices that detect parathyroid tissue in real-time during surgery - FDA Press Releases

FDA permits marketing of two devices that detect parathyroid tissue in real-time during surgery

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FDA and DoD formalize collaboration to advance medical products in support of American military personnel - FDA Press Releases

FDA and DoD formalize collaboration to advance medical products in support of American military personnel. New Memorandum of Understanding aligns agency efforts to foster the development and use of safe and effective medical products for members of the U.S. military.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s approval of Dsuvia and the FDA’s future consideration of new opioids - FDA Press Releases

FDA announces approval of Dsuvia and new steps the agency may be taking to evaluate opioids.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to address growing epidemic of youth e-cigarette use, including potential new therapies to support cessation - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to address growing epidemic of youth e-cigarette use, including potential new therapies to support cessation

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Quadrisphaera oryzae sp. nov., an endophytic actinomycete isolated from leaves of rice plant (Oryza sativa L.) - Journal of Antibiotics

Quadrisphaera oryzae sp. nov., an endophytic actinomycete isolated from leaves of rice plant (Oryza sativa L.)

<i>Quadrisphaera oryzae</i> sp. nov., an endophytic actinomycete isolated from leaves of rice plant (<i>Oryza sativa</i> L.), Published online: 02 November 2018; doi:10.1038/s41429-018-0112-5

Quadrisphaera oryzae sp. nov., an endophytic actinomycete isolated from leaves of rice plant (Oryza sativa L.)

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FDA warns patients and doctors about risk of inaccurate results from home-use device to monitor blood thinner warfarin - FDA Press Releases

Roche Diagnostics issued voluntary recall of certain test strips used with CoaguChek meter devices; patients affected by the recall should seek alternative methods for testing.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on findings from the romaine lettuce E. coli O157:H7 outbreak investigation and FDA’s efforts to prevent future outbreaks - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., on findings from the romaine lettuce E. coli O157:H7 outbreak investigation and FDA’s efforts to prevent future outbreaks

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Statement from Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health on the National Toxicology Program’s report on radiofrequency energy exposure - FDA Press Releases

Statement from Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health on the recent National Toxicology Program report release on radiofrequency energy exposure

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Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health and Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research on agency’s warning to consumers about genetic tests that claim to predict patients’ responses to specific medications - FDA Press Releases

FDA warns consumers about concerns with pharmacogenetic tests whose claims have not been reviewed by FDA

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