Stonewall Kitchen Voluntarily Recalls a Limited Amount of Basil Pesto Aioli due to Mislabeling and Undeclared Presence of the Dairy Allergen, Egg - FDA Safety Alerts & Drug Recalls

Stonewall Kitchen is voluntarily recalling a limited amount of 10.25oz Basil Pesto Aioli with an Enjoy By date of 28 Sep 2019 which may contain the undeclared allergen egg, as we may have inadvertently placed the label for our Basil Pesto on a small portion of our most recent production run.

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CMS Encourages Eligible Suppliers to Participate in Expanded Medicare Diabetes Prevention Program Model - CMS Blog

By CMS Administrator Seema Verma

Nationally expanded performance-based payment model now enrolling service suppliers

The Centers for Medicare & Medicaid Services (CMS) in April expanded the Medicare Diabetes Prevention Program (MDPP), a national performance-based payment model offering a new approach to type 2 diabetes prevention in eligible Medicare beneficiaries with an indication of pre-diabetes. For the first time, both traditional healthcare providers and community-based organizations can enroll as Medicare suppliers of health behavior change services. This innovative model promotes patient-centered care and continues to test market-driven reforms to drive quality of care and improve outcomes for America’s seniors, more than a quarter of whom have type 2 diabetes.

CMS recognizes that prevention is a critical part of creating an affordable healthcare system that puts patients first, and we encourage eligible suppliers to partner with us on this shared goal by participating in the national expansion of the MDPP.

As the CMS Innovation Center’s first preventive services model test to expand nationally, the MDPP is a key example of how we’re putting innovation to work. The model launched in 2012 as a small, voluntary model test at 17 sites across the country in partnership with the YMCA-USA, Centers for Disease Control and Prevention (CDC), and other public and private partners. Now, CMS is expanding this set of services nationwide based on promising results. In the initial model test, 45 percent of beneficiaries met the 5 percent weight loss target, which translates to a clinically meaningful reduction in the risk of developing type 2 diabetes.

Through the MDPP, trained community health workers and other health professionals empower beneficiaries at high risk of developing type 2 diabetes to take ownership of their health through curriculum-driven coaching and proven behavior change strategies for weight control. As a new preventive service for qualifying Medicare beneficiaries, MDPP services are available without a referral or co-payment.

The MDPP is not only a good value for our beneficiaries. Investing in prevention through performance-based payments and market-based incentives, this promising model will save the Medicare program more than $180 million by keeping beneficiaries healthy and averting new cases of diabetes[i].

One of the critical innovations in the MDPP is its approach to care delivery: For the first time, community-based organizations can enroll in Medicare to provide evidence-based diabetes prevention services after achieving preliminary or full recognition through the CDC. These organizations can enroll in Medicare to become an MDPP Supplier today, and CMS will continue to accept supplier applications on a rolling basis. Eligible organizations can begin the screening and enrollment process to become an MDPP Supplier by using the Provider Enrollment Chain and Ownership System (PECOS) or submitting the paper CMS-20134 Form. For information on the steps to enrollment, please refer to the MDPP Enrollment Fact Sheet.

Diabetes exerts an unacceptable toll on our beneficiaries, their families, and the Medicare program, which spends more than $104 billion every year treating patients with this preventable disease. The Medicare Diabetes Prevention Program is leveraging innovation to bring valuable preventive services to our beneficiaries, and I urge eligible organizations across the country to enroll today in this exciting performance-based payment opportunity.

[i] Federal Register. Department of Health and Human Services, Centers for Medicare and Medicaid Services. Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program; Final Rule. November 15, 2017. [pg. 53355 – 53356] https://www.gpo.gov/fdsys/pkg/FR-2017-11-15/pdf/2017-23953.pdf

 

 

 

 

 

 

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Van's Foods Voluntarily Recalls Gluten Free Waffles in Eleven States - FDA Safety Alerts & Drug Recalls

Van's Foods is voluntarily recalling approximately 1,584 cases of Van's Gluten Free Waffles with a lot code date of #A640234710–WL2, BEST BY AUG 22, 2018 and UPC CODE 8994730206. The products were distributed solely to food retailers in Arkansas, California, Colorado, Georgia, Illinois, Michigan, New Jersey, New York, Pennsylvania, Texas and Wisconsin.

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Ethnic Foods Inc. Issues Allergy Alert on Undeclared Peanuts in “Bhavnagri Mix” - FDA Safety Alerts & Drug Recalls

Ethnic Foods Inc. of 76 South Bayles Avenue, Port Washington, NY 11050, is recalling its 19 ounce package of Bhavnagri Mix snack mix because they may contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.

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Cyclo(Pro-DOPA), a third identified bioactive metabolite produced by Streptomyces sp. 8812 - Journal of Antibiotics

Cyclo(Pro-DOPA), a third identified bioactive metabolite produced by Streptomyces sp. 8812

Cyclo(Pro-DOPA), a third identified bioactive metabolite produced by <i>Streptomyces</i> sp. 8812, Published online: 26 April 2018; doi:10.1038/s41429-018-0059-6

Cyclo(Pro-DOPA), a third identified bioactive metabolite produced by Streptomyces sp. 8812

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Isolation of a jadomycin incorporating l-ornithine, analysis of antimicrobial activity and jadomycin reactive oxygen species (ROS) generation in MDA-MB-231 breast cancer cells - Journal of Antibiotics

Isolation of a jadomycin incorporating l-ornithine, analysis of antimicrobial activity and jadomycin reactive oxygen species (ROS) generation in MDA-MB-231 breast cancer cells

Isolation of a jadomycin incorporating <span class="small-caps">l</span>-ornithine, analysis of antimicrobial activity and jadomycin reactive oxygen species (ROS) generation in MDA-MB-231 breast cancer cells, Published online: 26 April 2018; doi:10.1038/s41429-018-0060-0

Isolation of a jadomycin incorporating l-ornithine, analysis of antimicrobial activity and jadomycin reactive oxygen species (ROS) generation in MDA-MB-231 breast cancer cells

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Anti-inflammatory phomalichenones from an endolichenic fungus Phoma sp. - Journal of Antibiotics

Anti-inflammatory phomalichenones from an endolichenic fungus Phoma sp.

Anti-inflammatory phomalichenones from an endolichenic fungus <i>Phoma</i> sp., Published online: 26 April 2018; doi:10.1038/s41429-018-0058-7

Anti-inflammatory phomalichenones from an endolichenic fungus Phoma sp.

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Labrada Nutrition Issues Allergy Alert on Undeclared Egg in "Leanpro8" Protein Powder - FDA Safety Alerts & Drug Recalls

Labrada Nutrition of Houston, TX, is recalling specific lots of its "LeanPro8" Protein Powder because they may contain undeclared egg protein. People who have allergies to egg protein run the risk of serious or life-threatening allergic reaction if they consume these products.

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Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for testimony before a U.S. Senate Committee on Appropriations on FDA’s Fiscal Year 2019 budget - FDA Press Releases

FDA Commissioner Scott Gottlieb, M.D. remarks to a U.S. Senate Subcommittee on Appropriations on the FDA’s Fiscal Year 2019 budget

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Statement from FDA Commissioner Scott Gottlieb, M.D., on new enforcement actions and a Youth Tobacco Prevention Plan to stop youth use of, and access to, JUUL and other e-cigarettes - FDA Press Releases

FDA announces several new enforcement actions and a Youth Tobacco Prevention Plan to stop youth use of, and access to, JUUL and other e-cigarettes.

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The activities of wortmannilactones against helminth electron transport chain enzymes, structure-activity relationships, and the effect on Trichinella spiralis infected mice - Journal of Antibiotics

The activities of wortmannilactones against helminth electron transport chain enzymes, structure-activity relationships, and the effect on Trichinella spiralis infected mice

The activities of wortmannilactones against helminth electron transport chain enzymes, structure-activity relationships, and the effect on <i>Trichinella spiralis</i> infected mice, Published online: 24 April 2018; doi:10.1038/s41429-018-0061-z

The activities of wortmannilactones against helminth electron transport chain enzymes, structure-activity relationships, and the effect on Trichinella spiralis infected mice

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Hamuramicins A and B, 22-membered macrolides, produced by an endophytic actinomycete Allostreptomyces sp. K12-0794 - Journal of Antibiotics

Hamuramicins A and B, 22-membered macrolides, produced by an endophytic actinomycete Allostreptomyces sp. K12-0794

Hamuramicins A and B, 22-membered macrolides, produced by an endophytic actinomycete <i>Allostreptomyces</i> sp. K12-0794, Published online: 24 April 2018; doi:10.1038/s41429-018-0055-x

Hamuramicins A and B, 22-membered macrolides, produced by an endophytic actinomycete Allostreptomyces sp. K12-0794

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Ziegenfelder Company Recalls Certain Ice Pops For Possible Health Risk - FDA Safety Alerts & Drug Recalls

As a precaution, the Ziegenfelder Company of Wheeling, WV is voluntarily recalling approximately 3,000 cases of Budget $aver Cherry Pineapple Monster Pops and Sugar Free Twin Pops because the products have the potential to be contaminated with Listeria monocytogenes. Listeria can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy individuals may suffer only short-term symptoms such as fever, headache, stiffness, nausea, abdominal pain and diarrhea, but Listeria infection can cause miscarriages and stillbirths among pregnant women.

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Voluntary Recall Notice of Happy Harvest Canned Spinach Due to Potential Undeclared Peanut Allergen from Product Mislabeling - FDA Safety Alerts & Drug Recalls

McCall Farms, Inc. is voluntarily recalling a limited amount of cases of Happy Harvest Spinach in 13.5 oz cans as a precautionary measure due to the potential presence of peanuts resulting from product mislabeling. This product may cause an allergic reaction in customers who have a peanut allergy.

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Giant Eagle Voluntarily Recalls Items Prepared with Romaine Lettuce Due to Potential E. coli Contamination - FDA Safety Alerts & Drug Recalls

Giant Eagle, Inc. is recalling multiple items prepared with romaine lettuce and sold in its Giant Eagle, Market District and GetGo locations across western Pennsylvania, Ohio, West Virginia, Maryland and Indiana. This recall is in response to a CDC notice on romaine lettuce sourced by a supply partner from the Yuma, Arizona growing region.

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FDA authorizes new use of test, first to identify the emerging pathogen Candida auris - FDA Press Releases

FDA authorized the first test to identify the emerging pathogen Candida auris, which can cause serious infections in hospitalized patients.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to encourage more widespread innovation and development of new treatments for opioid use disorder - FDA Press Releases

FDA announces new steps to encourage more widespread innovation and development of new treatments for opioid use disorder

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FDA takes new steps to advance the development of innovative products for treating opioid use disorder - FDA Press Releases

FDA announces new steps to encourage and support the development of treatment options for people with opioid use disorder

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Eataly USA Issues Allergy Alert on Undeclared Walnuts in Artichoke Spread - FDA Safety Alerts & Drug Recalls

Eataly USA of New York City, New York is recalling Eataly Artichoke Spread, because it may contain undeclared walnuts. People who have an allergy or severe sensitivity to walnuts run the risk of serious or life-threatening allergic reaction if they consume these products.

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Effect of antimicrobial peptides from Galleria mellonella on molecular models of Leishmania membrane. Thermotropic and fluorescence anisotropy study - Journal of Antibiotics

Effect of antimicrobial peptides from Galleria mellonella on molecular models of Leishmania membrane. Thermotropic and fluorescence anisotropy study

Effect of antimicrobial peptides from <i>Galleria mellonella</i> on molecular models of <i>Leishmania</i> membrane. Thermotropic and fluorescence anisotropy study, Published online: 20 April 2018; doi:10.1038/s41429-018-0050-2

Effect of antimicrobial peptides from Galleria mellonella on molecular models of Leishmania membrane. Thermotropic and fluorescence anisotropy study

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Identification and heterologous expression of the actinoallolide biosynthetic gene cluster - Journal of Antibiotics

Identification and heterologous expression of the actinoallolide biosynthetic gene cluster

Identification and heterologous expression of the actinoallolide biosynthetic gene cluster, Published online: 20 April 2018; doi:10.1038/s41429-018-0057-8

Identification and heterologous expression of the actinoallolide biosynthetic gene cluster

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A new protein tyrosine phosphatase 1B inhibitory α-pyrone-type polyketide from Okinawan plant-associated Aspergillus sp. TMPU1623 - Journal of Antibiotics

A new protein tyrosine phosphatase 1B inhibitory α-pyrone-type polyketide from Okinawan plant-associated Aspergillus sp. TMPU1623

A new protein tyrosine phosphatase 1B inhibitory α-pyrone-type polyketide from Okinawan plant-associated <i>Aspergillus</i> sp. TMPU1623, Published online: 20 April 2018; doi:10.1038/s41429-018-0054-y

A new protein tyrosine phosphatase 1B inhibitory α-pyrone-type polyketide from Okinawan plant-associated Aspergillus sp. TMPU1623

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Federal judge enters consent decree against Cantrell Drug Company - FDA Press Releases

Cantrell Drug Company prohibited from manufacturing and distributing sterile drug products in violation of the law

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Superior Foods Company Voluntarily Recalls 487 lbs. of Smoked Salmon Spreads - FDA Safety Alerts & Drug Recalls

Superior Foods Company located in Kentwood, Michigan is voluntarily recalling a specific lot of Smoked Salmon Spreads (487 lbs.) that were produced on March 26, 2018. This voluntary action is being undertaken in cooperation with the U.S. Food and Drug Administration and the Michigan Department of Agriculture and Rural Development.

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NGB Corp. Recalls NxtGen Botanicals Maeng Da Kratom Because of Possible Salmonella Contamination - FDA Safety Alerts & Drug Recalls

NGB Corp. of West Jordan, Utah is voluntarily recalling NxtGen Botanicals Maeng Da Kratom labeled bottles of encapsulated product because it has the potential to 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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Cationic amphiphilic bolaamphiphile-based delivery of antisense oligonucleotides provides a potentially microbiome sparing treatment for C. difficile - Journal of Antibiotics

Cationic amphiphilic bolaamphiphile-based delivery of antisense oligonucleotides provides a potentially microbiome sparing treatment for C. difficile

Cationic amphiphilic bolaamphiphile-based delivery of antisense oligonucleotides provides a potentially microbiome sparing treatment for <i>C. difficile</i>, Published online: 19 April 2018; doi:10.1038/s41429-018-0056-9

Cationic amphiphilic bolaamphiphile-based delivery of antisense oligonucleotides provides a potentially microbiome sparing treatment for C. difficile

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Design, synthesis, biological activity and structure-activity relationship studies of chalcone derivatives as potential anti-Candida agents - Journal of Antibiotics

Design, synthesis, biological activity and structure-activity relationship studies of chalcone derivatives as potential anti-Candida agents

Design, synthesis, biological activity and structure-activity relationship studies of chalcone derivatives as potential anti-<i>Candida</i> agents, Published online: 19 April 2018; doi:10.1038/s41429-018-0048-9

Design, synthesis, biological activity and structure-activity relationship studies of chalcone derivatives as potential anti-Candida agents

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TruPet LLC Recalls Boost Me Mighty Meaty Beef Topper Meal Enhancer Because of Possible Salmonella Contamination - FDA Safety Alerts & Drug Recalls

TruPet, LLC of Milford, OH, is voluntarily recalling a limited amount of Boost Me Mighty Meaty Beef Topper Meal Enhancer because the products have the potential to be contaminated with Salmonella. The recall is limited to 400 cases of the product, as identified below.

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Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for testimony before U.S. House Committee on Appropriations on FDA’s Fiscal Year 2019 budget - FDA Press Releases

FDA Commissioner Scott Gottlieb, M.D. remarks to the U.S. House Committee on Appropriations on the FDA’s Fiscal Year 2019 budget

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FDA approves first therapy for rare inherited form of rickets, x-linked hypophosphatemia - FDA Press Releases

FDA approved Crysvita (burosumab), the first drug approved to treat adults and children ages 1 year and older with x-linked hypophosphatemia (XLH), a rare form of rickets.

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Statement by Dr. Susan Mayne on FDA efforts to reduce consumer exposure to arsenic in rice - FDA Press Releases

One way FDA oversees food safety is through monitoring of contaminants in food, such as arsenic, assessing potential exposure and taking steps to reduce exposure

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World’s Best Cheese Recalls l’Explorateur Soft Ripened Cheese Due to Possible Health Risk - FDA Safety Alerts & Drug Recalls

World’s Best Cheeses of Armonk, NY is recalling 22 cases of Formagerie de la Brie brand, l’Explorateur soft ripened cheese because it has the potential to be contaminated with Listeria monocytogenes, 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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Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to enhance and modernize the FDA’s approach to medical device safety and innovation - FDA Press Releases

The FDA is releasing the Medical Device Safety Action Plan that outlines our vision for how FDA can continue to enhance our programs and processes to assure the safety of medical devices

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Cal-Maine Foods, Inc. Announces Voluntary Shell Egg Recall Due to Possible Health Risk - FDA Safety Alerts & Drug Recalls

Cal-Maine Foods, Inc. (NASDAQ: CALM) today announced the Company was notified after the close of business on April 13, 2018, by Rose Acre Farms of Seymour, Indiana, of a voluntary egg recall. The eggs involved in the recall have the potential to be contaminated with Salmonella Braenderup and were distributed from Rose Acre Farms’ Hyde County, North Carolina, facility from January 11, 2018, through April 12, 2018.

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Two new spliceostatin analogs from the strain Pseudomonas sp. HS-NF-1408 - Journal of Antibiotics

Two new spliceostatin analogs from the strain Pseudomonas sp. HS-NF-1408

Two new spliceostatin analogs from the strain <i>Pseudomonas</i> sp. HS-NF-1408, Published online: 17 April 2018; doi:10.1038/s41429-018-0052-0

Two new spliceostatin analogs from the strain Pseudomonas sp. HS-NF-1408

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FDA orders mandatory recall for kratom products due to risk of salmonella - FDA Safety Alerts & Drug Recalls

MANDATORY RECALL ordered for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC

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Vitakraft Sun Seed Recalls of Sunseed Vita Prima Sugar Glider Food Due to Possible Salmonella Health Risk - FDA Safety Alerts & Drug Recalls

Vitakraft Sun Seed Inc. of Weston, OH, is voluntarily recalling one lot of Sunseed Vita Prima Exotics Sugar Glider Formula because it has the potential to be contaminated with Salmonella. Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.

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Polyketides from two Chaetomium species and their biological functions - Journal of Antibiotics

Polyketides from two Chaetomium species and their biological functions

Polyketides from two <i>Chaetomium</i> species and their biological functions, Published online: 16 April 2018; doi:10.1038/s41429-018-0047-x

Polyketides from two Chaetomium species and their biological functions

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K9 Natural Ltd Voluntarily Recalls K9 Natural Frozen Chicken Feast Raw Pet Food 2.2lb And 11lb Bags Because Of Possible Listeria Monocytogenes - FDA Safety Alerts & Drug Recalls

K9 Natural Ltd is voluntarily recalling four batches of the K9 Natural Frozen Chicken Feast 2.2lb and 11lb bags that was imported into the US market in June 2017 because they have the potential to be contaminated with Listeria Monocytogenes.

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Urgent: Voluntary Product Recall of Vuse Vibe Power Units - FDA Safety Alerts & Drug Recalls

R.J. Reynolds Vapor Company has voluntarily initiated a nationwide safety recall of all Vuse Vibe power units. The Company initiated the recall after receiving consumer complaints about malfunctioning batteries, which may cause the power unit to overheat and create a fire risk. The Company notified the U.S. Food and Drug Administration regarding the issue and will be working directly with the Agency on this voluntary recall.

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Forthcoming Issue - Geriatrics

Care for the Older Adult in the Emergency Department

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Contents - Geriatrics

Karen M. Kost

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Contributors - Geriatrics

KAREN M. KOST, MD, FRCSC

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Copyright - Geriatrics

ELSEVIER

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Geriatric Otolaryngology - Geriatrics

CLINICS IN GERIATRIC MEDICINE

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Geriatric Otolaryngology: Why It Matters - Geriatrics

Historically, young children have always outnumbered older people. In what is a shifting global trend well known to the readers of this text, people over the age of 65 will, for the first time, soon outnumber children under the age of five. As a consequence of declining birth rates and increasing life spans, the geriatric age group is the fastest growing segment of our society.1

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Thyroid Disorders in the Elderly - Geriatrics

Medical care for elderly patients is often distinctly different from that of younger counterparts. This is no truer than in a thyroid disorder context, where patients are often asymptomatic and polypharmacy is a potential consideration. Understanding how treatment of these patients can deviate from common practices is an essential asset to any health care provider. The purpose of this article is to shed light on those deviations and address inherent complexities in caring for elderly patients in an effort to improve quality of care. Topics considered range from general anatomic challenges to underlying biochemistry to adjuvant therapy options and surveillance.

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Voice Disorders in the Elderly - Geriatrics

Presbyphonia is more common than appreciated by most physicians, and it is associated with undesirable vocal characteristics such as hoarseness, weakness, breathiness, instability, and tremulousness. Hearing impairment in the patient or his or her friends, family, and associates exacerbates the problem, resulting in depression and social withdrawal, further reducing quality of life. Moreover, voice weakness and instability are all too often misinterpreted as reflecting intellectual instability. Expert diagnosis, medical treatment, voice therapy and training, and occasionally surgery usually can maintain or restore vocal stability and “youth.”

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Sleep Disorders in the Elderly - Geriatrics

Although some physiologic changes in sleep are a normal part of the aging process, other sleep complaints made by elderly patients can indicate a primary or secondary sleep disorder. It is important to recognize the difference between normal age-related changes and what may require further testing to make an accurate diagnosis. Proper diagnosis and treatment of sleep disorders can improve the quality of life and safety for the elderly and their families.

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Geriatric Dysphagia - Geriatrics

Geriatric dysphagia is an unrecognized and underdiagnosed problem with significant morbidity and potential mortality. It requires diligence by the clinician and a team approach for successful management. Careful history-taking is the key in the treatment of these patients and determines further workup, as well as treatment.

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La FDA toma medidas para proteger a los consumidores de los suplementos alimenticios que contienen niveles peligrosamente altos de cafeína altamente concentrada o pura - FDA Press Releases

: El día de hoy, la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) tomó una medida importante para proteger mejor a los consumidores de los peligros de los productos de cafeína altamente concentrada y pura.

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Seacrest Foods Recalls l’Explorateur Soft Ripened Cheese Due to Possible Health Risk - FDA Safety Alerts & Drug Recalls

Seacrest Foods International, Inc. of Lynn, MA is voluntarily recalling 29 cases of Formagere de la Brie brand, l’Explorateur soft ripened cheese because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, pregnant women 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, stillbirths and fetal infection among pregnant women.

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'Rhino 69 Extreme 50000' Recalled due to Presence of Active Ingredient 'Tadalafil' - FDA Safety Alerts & Drug Recalls

AMA Wholesale Inc. (Distributor/Re-seller), is voluntarily recalling Rhino 69 Extreme 50000 capsules to the consumer level. FDA analysis found the product to be tainted with undeclared tadalafil. Tadalafil is an active ingredient in a FDA-approved prescription drug that is used for erectile dysfunction.

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FDA takes step to protect consumers against dietary supplements containing dangerously high levels of extremely concentrated or pure caffeine - FDA Press Releases

Today, the U.S. Food and Drug Administration took an important step to better protect consumers from the dangers of highly concentrated and pure caffeine products.

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Guixens Food Group Issues Allergy Alert on Undeclared Sulfites in La Marinera Brand Dried Yellow Potatoes - FDA Safety Alerts & Drug Recalls

Guixens Food Group, Inc., of Miami, FL, is voluntarily recalling its ten-ounce packages of La Marinera Brand Dried Yellow Potatoes because it may contain undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume this product.

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FDA finalizes guidances to accelerate the development of reliable, beneficial next generation sequencing-based tests - FDA Press Releases

The FDA today finalized two guidances to drive the efficient development of a novel technology that scans a person’s DNA to diagnose genetic diseases, which are usually hereditary, and guide medical treatments.

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Glycosylated piericidins from an endophytic streptomyces with cytotoxicity and antimicrobial activity - Journal of Antibiotics

Glycosylated piericidins from an endophytic streptomyces with cytotoxicity and antimicrobial activity

Glycosylated piericidins from an endophytic streptomyces with cytotoxicity and antimicrobial activity, Published online: 12 April 2018; doi:10.1038/s41429-018-0051-1

Glycosylated piericidins from an endophytic streptomyces with cytotoxicity and antimicrobial activity

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Premier Pharmacy Labs Issues Voluntary Nationwide Recall of Specific Sterile Injectable Products Lots Due to a Potential Lack of Sterility Assurance - FDA Safety Alerts & Drug Recalls

Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.

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FDA permits marketing of artificial intelligence-based device to detect certain diabetes-related eye problems - FDA Press Releases

FDA permits marketing of first medical device to use artificial intelligence to detect greater than a mild level of diabetic retinopathy in the eye of adults who have diabetes.

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FDA clears first contact lens with light-adaptive technology - FDA Press Releases

FDA clears first contact lens with additive that automatically darkens the lens when exposed to bright light

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Nine Whole Foods Market Stores Issue Voluntary Recall for Explorateur French Triple Creme Cheese Due to Possible Health Risk - FDA Safety Alerts & Drug Recalls

Whole Foods Market is voluntarily recalling Explorateur French Triple Crème cheese from nine stores located in New Mexico, Texas, Arkansas, Illinois, Connecticut and New Jersey out of an abundance of caution. The cheese has the potential to be contaminated with Listeria monocytogenes.

from Food and Drug Administration--Recalls/Safety Alerts https://ift.tt/2GNIppb
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Stewart’s Shops Issues Allergy Alert on Pint Chocolate Peanut Butter Cup Ice Cream - FDA Safety Alerts & Drug Recalls

Stewart’s Shops Corp. is recalling units of Stewart’s pint Chocolate Peanut Butter Cup ice cream because they may have been packaged incorrectly with a “Chocolate” lid. People who have an allergy to peanuts run the risk of serious or life-threatening allergic reaction if they consume this product.

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FDA restricts sale and distribution of Essure to protect women and to require that patients receive risk information - FDA Press Releases

FDA is restricting the sale and distribution of the Essure device to only those health care providers who provide information to women about the risks and benefits of this device before they get the permanent contraception implant.

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Club 13 Recalls Kratom Maeng Da Red Powder and Capsules Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Club 13 of St. Augustine, FL is recalling 15-gram, 30-gram, 90-gram, 150-gram, and 454-gram pouches, and all bulk orders of "Maeng Da Red" kratom powder; and 5-count, 25-count, 50-count, 100-count, 120-count capsule, and all bulk capsule orders of “Maeng Da Red” kratom bottles; and 5-count, 20-count, 25-count, 40-count, 50-count capsule “Maeng Da Red XS” kratom bottles because they have the potential to 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. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

from Food and Drug Administration--Recalls/Safety Alerts https://ift.tt/2GMgkTq
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Bob’s Red Mill Natural Foods, Inc. Voluntarily Recalls Organic Amaranth Flour (22 Oz.) Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Bob’s Red Mill Natural Foods is voluntarily recalling 2,099 cases of Organic Amaranth Flour (22 oz.), after recent testing revealed the presence of Salmonella in a single LOT of Organic Amaranth Flour (22 oz.) with a Sell By date of Nov. 26, 2015.

from Food and Drug Administration--Recalls/Safety Alerts https://ift.tt/2GHPqb2
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Cut Fruit Express, Inc. Announces A Voluntary Recall of Fresh Bruschetta Mixed and Dips Because of Undeclared Soy and Milk - FDA Safety Alerts & Drug Recalls

Cut Fruit Express, Inc. of Inver Grove Heights, Minnesota is voluntarily recalling packaged Bruschetta Mixes and Dips distributed through 4/4/2018, with Use-by Dates as listed below, since they may contain undeclared milk and soy. People who have an allergy or severe sensitivity to milk or soy run the risk of serious or life-threatening allergic reaction if they consume these products.

from Food and Drug Administration--Recalls/Safety Alerts https://ift.tt/2uRBmul
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Advocare Issues Allergy Alert in Select Bottles of Muscle Strength and Nighttime Recovery Product Because of Undeclared Milk Allergen on The Label - FDA Safety Alerts & Drug Recalls

AdvoCare International has commenced a voluntary recall of two lots of Muscle Strength and four lots of Nighttime Recovery dietary supplements because they may contain undeclared milk that can elicit an allergic reaction in individuals who are sensitive to milk and milk products.

from Food and Drug Administration--Recalls/Safety Alerts https://ift.tt/2GCN5lT
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Independent Nutrition, Inc Issues Allergy Alert On Undeclared Milk in Ignite Pre-Workout Supplement Products - FDA Safety Alerts & Drug Recalls

April 5, 2018, Independent Nutrition Inc, dba Back to Health of Eugene, Oregon is recalling certain lots of the Ignite High Endurance Pre-Workout Supplement products because it may contain undeclared milk. People who have an allergy or sever sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

from Food and Drug Administration--Recalls/Safety Alerts https://ift.tt/2q9tMpM
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Aspire Food Group Issues Alert on Undeclared Sulfites in Exo Bars - FDA Safety Alerts & Drug Recalls

Aspire Food Group of Austin, TX, is recalling its 60 gram bars of EXO Blueberry Vanilla, Peanut Butter & Jelly, and Apple Cinnamon bars because they may contain undeclared sulfites. People who have a severe sensitivity to sulfites run the risk of serious or life-threatening reaction if they consume these products.

from Food and Drug Administration--Recalls/Safety Alerts https://ift.tt/2HfZ5qr
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Recall of Certain Lots of Izzy’s Maple Nut Ice Cream Due to Undeclared Peanuts - FDA Safety Alerts & Drug Recalls

Izzy’s Ice Cream, LLC is voluntarily recalling limited numbers of its Maple Nut Ice Cream pints following a supplier’s recall of walnuts due to the possible presence of undeclared peanut residue. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products

from Food and Drug Administration--Recalls/Safety Alerts https://ift.tt/2GYx8pf
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Global Commodities Corporation Recalls Buenas Grated Coconut due to Possible Health Risk - FDA Safety Alerts & Drug Recalls

Global Commodities Corporation, Hayward, CA is recalling one lot of Buenas Brand frozen grated coconut because they have the potential to 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. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

from Food and Drug Administration--Recalls/Safety Alerts https://ift.tt/2El0eK6
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Reclassification of Nocardia species based on whole genome sequence and associated phenotypic data - Journal of Antibiotics

Reclassification of Nocardia species based on whole genome sequence and associated phenotypic data

Reclassification of <i>Nocardia</i> species based on whole genome sequence and associated phenotypic data, Published online: 04 April 2018; doi:10.1038/s41429-018-0043-1

Reclassification of Nocardia species based on whole genome sequence and associated phenotypic data

from The Journal of Antibiotics - Issue - nature.com science feeds https://ift.tt/2GUc5Eo
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Roquefortine J, a novel roquefortine alkaloid, from the deep-sea-derived fungus Penicillium granulatum MCCC 3A00475 - Journal of Antibiotics

Roquefortine J, a novel roquefortine alkaloid, from the deep-sea-derived fungus Penicillium granulatum MCCC 3A00475

Roquefortine J, a novel roquefortine alkaloid, from the deep-sea-derived fungus <i>Penicillium granulatum</i> MCCC 3A00475, Published online: 04 April 2018; doi:10.1038/s41429-018-0046-y

Roquefortine J, a novel roquefortine alkaloid, from the deep-sea-derived fungus Penicillium granulatum MCCC 3A00475

from The Journal of Antibiotics - Issue - nature.com science feeds https://ift.tt/2IpmKUL
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Nutrizone Expands Recall of Various Lots of Multiple Dietary Supplements Because of Possible Salmonella Health Risk - FDA Safety Alerts & Drug Recalls

NutriZone, LLC is adding Nirvanio Special Reserve Kratom Blend, to its recall of 4 dietary supplements because it has the potential to be contaminated with Salmonella . Salmonella , is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

from Food and Drug Administration--Recalls/Safety Alerts https://ift.tt/2Gvk3jU
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FDA Orders Mandatory Recall for Kratom Products Due to Risk of Salmonella - FDA Safety Alerts & Drug Recalls

Today, the U.S. Food and Drug Administration announced it has issued a mandatory recall order for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several were found to contain salmonella. The agency took this action after the company failed to cooperate with the FDA’s request to conduct a voluntary recall. This is the first time the agency has issued a mandatory recall order to protect Americans from contaminated food products.

from Food and Drug Administration--Recalls/Safety Alerts https://ift.tt/2Jhl2WD
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FDA orders mandatory recall for kratom products due to risk of salmonella - FDA Press Releases

Today, the U.S. Food and Drug Administration announced it has issued a mandatory recall order for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several were found to contain salmonella. The agency took this action after the company failed to cooperate with the FDA’s request to conduct a voluntary recall. This is the first time the agency has issued a mandatory recall order to protect Americans from contaminated food products.

from Food and Drug Administration--Press Releases https://ift.tt/2IowoXB
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Nutrizone Recalls Various Lots of Multiple Dietary Supplements Because of Possible Salmonella Health Risk - FDA Safety Alerts & Drug Recalls

NutriZone, LLC of Houston, Texas is recalling 4 different dietary supplements because it has the potential to be contaminated with Salmonella. Salmonella, is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

from Food and Drug Administration--Recalls/Safety Alerts https://ift.tt/2Innzxh
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New York raw milk cheese company ordered to stop sales for food safety violations - FDA Press Releases

FDA announces an enforcement action taken against Vulto Creamery of New York. The company cannot sell ready-to-eat raw cheese product until it complies with the consent decree. Vulto was linked to an outbreak last year.

from Food and Drug Administration--Press Releases https://ift.tt/2q05n5v
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