AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material - FDA Safety Alerts & Drug Recalls

East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling two lots of Piperacillin and Tazobactam for injection, USP 3.375 g (Piperacillin Sodium equivalent to 3 g of Piperacillin USP and Tazobactam Sodium equivalent to 0.375 g of Tazobactam USP. Each vial contains 7.05 mEq (162 mg) of Sodium) in a Single-Dose vial, to the hospital level. One vial from lot# PP0317012-A was found to contain particulate matter, identified as glass within the vial and another vial from lot# PP0317059-A was found to contain silicone material. This problem was discovered as a result of two product complaints in which the contents of one vial from batch PP0317012-A was found to contain a glass particle and the contents of one vial from batch PP0317059A was found to contain a silicone particle.

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ADM Animal Nutrition Recalls Mintrate® 36-15 Breed Right Cattle Tub - A specific lot of product may contain elevated levels of non-protein nitrogen, could harm cattle - FDA Safety Alerts & Drug Recalls

ADM Animal Nutrition, a division of Archer Daniels Midland Company (NYSE: ADM), is recalling 200-pound tubs of Mintrate® 36-15 Breed Right Tub cattle feed, product number 54549AAA6H, because the product may contain elevated levels of non-protein nitrogen, which could be harmful to cattle. Excessive levels of non-protein nitrogen can be toxic to cattle and can cause muscle tremors (especially of face and ears), abdominal pain, bloat, frothy salivation, excessive urination, teeth grinding, incoordination, weakness, shortness of breath and possible death.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new efforts to advance antimicrobial stewardship in veterinary settings - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new efforts to advance antimicrobial stewardship in veterinary settings

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FDA approves first treatment for rare adrenal tumors - FDA Press Releases

FDA approves first treatment for rare adrenal tumors

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Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to safeguard women’s health from deceptive health claims and significant risks related to devices marketed for use in medical procedures for “vaginal rejuvenation” - FDA Press Releases

FDA warns doctors and patients about deceptive claims on laser medical devices used to treat menopausal symptoms for “vaginal rejuvenation”

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Lipari Foods Issues Voluntary Recall of Premo Brand & Fresh Grab Turkey & Swiss Submarine Sandwiches Due to Potential Contamination of Listeria Monocytogenes - FDA Safety Alerts & Drug Recalls

Lipari Foods, LLC has issued a voluntary recall of Premo Brand and Fresh Grab turkey and Swiss submarine sandwiches produced and packaged by sister company JLM due to potential contamination of 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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Ranier’s Rx Laboratory Issues Voluntary Recall of All Sterile Compounded Products Within Expiry Due to Lack of Sterility Concerns - FDA Safety Alerts & Drug Recalls

Ranier’s Rx Laboratory is voluntarily recalling all sterile compounded drug products within expiry to the hospital or consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA.

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TeaSource Issues Allergy Alert on Undeclared Almonds in Product - FDA Safety Alerts & Drug Recalls

TeaSource of Roseville, MN is recalling Roasted Chestnut loose leaf tea, because it may contain undeclared almonds. People who have an allergy or severe sensitivity to almonds run the risk of serious or life-threatening allergic reaction if they consume this product

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Statement from FDA Commissioner Scott Gottlieb, M.D., on the process FDA is undertaking for reviewing and modernizing the agency’s standards of identity for dairy products - FDA Press Releases

Process FDA is undertaking for reviewing and modernizing the agency’s standards of identity for dairy products

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5-Aminosalicylic acid downregulates the growth and virulence of Escherichia coli associated with IBD and colorectal cancer, and upregulates host anti-inflammatory activity - Journal of Antibiotics

5-Aminosalicylic acid downregulates the growth and virulence of Escherichia coli associated with IBD and colorectal cancer, and upregulates host anti-inflammatory activity

5-Aminosalicylic acid downregulates the growth and virulence of <i>Escherichia coli</i> associated with IBD and colorectal cancer, and upregulates host anti-inflammatory activity, Published online: 26 July 2018; doi:10.1038/s41429-018-0081-8

5-Aminosalicylic acid downregulates the growth and virulence of Escherichia coli associated with IBD and colorectal cancer, and upregulates host anti-inflammatory activity

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AMPI Recalls Limited Amount of Dry Whey Powder Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Associated Milk Producers Inc. (AMPI) of New Ulm, Minn., is recalling dry whey powder packaged in 50-pound and 25-kg bags that were produced at the cooperative’s Blair, Wis., dry whey plant from May 1-5, 2018; May 24-29, 2018; June 2-5, 2018; and June 7-14, 2018 due to the potential to be contaminated with Salmonella. This is a precautionary recall. All products shipped to the marketplace tested negative for Salmonella.

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Kraft Heinz Voluntarily Recalls Taco Bell Salsa Con Queso Mild Cheese Dip Distributed to Retailers - FDA Safety Alerts & Drug Recalls

As a precaution, approximately 7,000 cases of Taco Bell Salsa Con Queso Mild Cheese Dip are being voluntarily recalled because the affected product is showing signs of product separation which can lead to a potential health hazard. This could create conditions that could allow for the growth of Clostridium botulinum (C. botulinum), a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.

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Pepperidge Farm® Announces Voluntary Recall of Four Varieties of Goldfish® Crackers - FDA Safety Alerts & Drug Recalls

Pepperidge Farm has been notified by one of its ingredient suppliers that whey powder in a seasoning that is applied to four varieties of crackers has been the subject of a recall by the whey powder manufacturer due to the potential presence of Salmonella. Pepperidge Farm initiated an investigation and, out of an abundance of caution, is voluntarily recalling four varieties of Goldfish crackers. The products were distributed throughout the United States. No illnesses have been reported. No other Pepperidge Farm products in the U.S. are subject to this recall.

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Statement from FDA Commissioner Scott Gottlieb, M.D. on voluntary recalls of Ritz, Goldfish and other products issued out of an abundance of caution - FDA Press Releases

The U.S. Food and Drug Administration is working with Mondelēz International, Inc., Pepperidge Farm Inc. and Flowers Foods, Inc. to initiate voluntarily recalls of certain products due to a potential risk that one of the ingredients may have been contaminated with Salmonella.

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FDA approves magnetic device system for guiding sentinel lymph node biopsies in certain patients with breast cancer - FDA Press Releases

FDA approves magnetic device system for guiding sentinel lymph node biopsies in certain patients with breast cancer

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Flowers Foods Issues Voluntary Recall on Mrs. Freshley’s and Other Brands of Swiss Rolls and Captain John Derst’s Old Fashioned Bread - FDA Safety Alerts & Drug Recalls

As a precautionary measure, Flowers Foods, Inc. (NYSE: FLO) is voluntarily recalling Swiss Rolls sold under the brand names Mrs. Freshley’s, Food Lion, H-E-B, Baker’s Treat, Market Square, and Great Value, distributed nationwide, and Captain John Derst’s Old Fashioned Bread distributed in Alabama, Florida, Georgia, North Carolina, and South Carolina, due to the potential presence of Salmonella in an ingredient, whey powder. The ingredient recall was initiated by a third-party whey powder manufacturer and supplier. No illnesses have been reported in connection with the recalled items. See below for list of UPC #s and “best by” dates.

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Mondelēz Global LLC Conducts Voluntary Recall of Certain Ritz Cracker Sandwiches and Ritz Bits Product in the U.S., including Puerto Rico & U.S. Virgin Islands Due to Possible Health Risk - FDA Safety Alerts & Drug Recalls

Mondelēz Global LLC announced today a voluntary recall in the United States, including Puerto Rico & the U.S. Virgin Islands, of certain Ritz Cracker Sandwiches and Ritz Bits product. These products contain whey powder as an ingredient, which the whey powder supplier has recalled due to the potential presence of Salmonella.

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FDA continues taking key actions on bulk drug substances used for compounding to advance the regulatory framework governing compounded drugs and to protect patients - FDA Press Releases

FDA continues making progress on bulk drug substances for compounding

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GiftTree Issues Allergy Alert on Undeclared Pecans, Walnuts, Almonds, Peanuts in " Sherman Candy Caramels " - FDA Safety Alerts & Drug Recalls

GiftTree, a gift basket company based in Vancouver, WA, is voluntarily recalling 94,000 units of “Sherman Candy Caramels” sold online in the several Gift Baskets because they may contain undeclared pecans, walnuts, almonds and/or peanuts. People who have an allergy or severe sensitivity to these nuts run the risk of serious or life-threatening reaction if they consume this product.

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Allergy Alert for Undeclared Milk in Food Lion Brand Dill Pickle Flavored Potato Chips - FDA Safety Alerts & Drug Recalls

Shearer’s Foods, LLC of Massillon, OH is recalling Food Lion brand 7.75 ounce packages of Dill Pickle Flavored Potato Chips 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. The recalled Dill Pickle Flavored Potato Chips were distributed to Food Lion stores in NC, SC, GA, PA, KY, VA, TN, DE, MD, and WV between Dec 1st, 2017 and July 19, 2018.

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King Bio Issues Voluntary Nationwide Recall of Aquaflora Candida HP9, Lymph Detox, and Baby Teething Liquids Due to Microbial Contamination - FDA Safety Alerts & Drug Recalls

King Bio is voluntarily recalling four lots of Aquaflora Candida HP9, Lymph Detox, and Baby Teething liquids to the consumer level. During a routine inspection by the U.S. Food and Drug Administration, the products were found to contain microbial contaminants Pseudomonas Brenneri, Pseudomonas Fluroescens and Burkholderia Multivorans.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on manufacturer announcement to halt Essure sales in the U.S.; agency’s continued commitment to postmarket review of Essure and keeping women informed - FDA Press Releases

The FDA responds to Bayer’s announcement to halt Essure sales in the US

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FDA approves first targeted treatment for patients with relapsed or refractory acute myeloid leukemia who have a certain genetic mutation - FDA Press Releases

FDA approves new drug for the treatment of adults with acute myeloid leukemia who have a specific genetic mutation and a companion diagnostic to detect specific mutations in the IDH1 gene in patients with AML

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Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to encourage the development of and broaden access to generic versions of opioid analgesics that are formulated to deter abuse - FDA Press Releases

FDA posted a new batch of 43 product-specific guidances related to the development of generic drug products that includes three revised product-specific guidances for ADF opioid products. These guidances recommend specific in vivo studies and in vitro study considerations for abuse deterrence evaluations.

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Statement from FDA warning about significant health risks of contaminated illegal synthetic cannabinoid products that are being encountered by FDA - FDA Press Releases

Statement from FDA warning about significant health risks of contaminated illegal synthetic cannabinoid products that are being encountered by FDA

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CMS Doubling Down on Health IT; Patients - CMS Blog

By Seema Verma, Administrator, Centers for Medicare & Medicaid Services

Americans enjoy the benefits of the best healthcare providers and innovators in the world. Yet while the volume of care consumed by American patients has not increased dramatically comparative to similar economies, the cost of care in the United States has accelerated at an alarming pace. Healthcare costs continue to grow faster than the U.S. GDP, making it more difficult with each passing year for CMS to ensure healthcare to not only its beneficiaries of today, but generations of beneficiaries in the future.

We believe at CMS that a major cause for the cost inefficiency of healthcare is attributable to a failure in the past to make the system about the patient and for the patient. It is the system that has become the centerpiece of policy debates, and it is the system that has become more about sustaining itself than serving patients. If the patient truly is what our healthcare system seeks to serve, then the patient must be the focal point of all policies and private industry decision-making.

CMS is committed to leveraging innovation to truly empower patients with their own data, decisions, and care. Evidence of this commitment can be found in a government-wide initiative launched by CMS and the White House Office of Innovation in March called MyHealthEData— designed to achieve true patient control and interoperability of their health records, and to enable patients to share their data with technology innovators and researchers to accelerate public health. See our new video for a simple explanation of MyHealthEData.

At CMS we are putting patients first, and we are moving to break down silos of patient information that is being captured by the system, and depriving the patient the access to the best quality, and most affordable care. Sustaining our exceptional healthcare depends now more than ever on driving down costs, and a major part of the CMS strategy to drive down costs depends on smart and innovative use of information technology (IT).

Through MyHealthEData, CMS envisions a future in which all patients have access to their own health data and use it to make the right decisions for themselves and to get the best value. We see health IT systems that work seamlessly with each other, and a government that supports secure data sharing and emerging technologies so that healthcare in America is better and less expensive.

To achieve these goals, CMS fully acknowledges that we cannot operate in a “way-we-have-always-done-it” manner and hope for different results. That is why CMS created the new role of CMS Chief Health Informatics Officer (CHIO) and has begun the process of filling this new role with a leading healthcare IT talent. The CHIO will drive health IT and data sharing to enhance healthcare delivery, improve health outcomes, drive down costs, and empower patients. Through this new function, CMS will effectively engage stakeholders from all parts of the healthcare market, including our Federal partners and industry leaders.

As CMS Administrator, I am deeply committed to programs, policies, and systems that put patients first. It’s 2018—most doctors are using electronic health records (EHRs) and most patients have access to the Internet and a smartphone, providing many ways to view healthcare data securely. Patients should expect health IT that enhances their care coordination instead of disrupting it. Their information should automatically follow them to all of their healthcare providers, so that everyone stays informed and can provide the best treatment. Patients also should know how much a health service costs so they can decide whether they want it, and “shop around” for where to get it.

Another reason behind our decision to create a CHIO role is that today at CMS, we are focused on data, not only to inform our strategy, but also to promote patient choice and drive down cost. We are evaluating the data we have and how best to apply it to our mission. We also are thinking about an Application Programming Interface (API) strategy across the entire agency that will allow us to securely provide data so that software developers, researchers, and others can design useful products (such as apps) powered by it, just as so many companies do to enhance their customer experience.

If we can solve these health IT challenges, not only will patients benefit, but so too will providers and payers. We are closer than ever to realizing these goals, but we are not there yet.

The truth is, as the largest healthcare payer in the country, CMS should have had a CHIO function long ago. Despite today’s amazing technology and decades of promises, we are not where we should be. The CHIO role will enhance my leadership team, working across CMS, with federal partners including the U.S. Digital Service, and alongside private industry and researchers to lead innovation and help inform CMS’s health IT strategy. The challenge is great, but so is the reward—building the next generation of interoperable health systems for millions of Americans and affecting national and global health IT for good.

We now have the momentum and focus to make this happen.

Although we will refine specific responsibilities, we anticipate the CHIO role will help drive forward the many health IT initiatives we have begun this year, including the Medicare Blue Button 2.0 program—a universal digital format for personal health information—and our overhaul of the CMS EHR Incentive Programs to focus on interoperability.

I look forward to meeting qualified CHIO candidates who wish to step up to this challenge and join the team that will lead CMS health IT over the “finish line” so that we can drive down costs and save lives. The time is now to realize the true potential of health IT for America’s patients.

###

Get CMS news at cms.gov/newsroom, sign up for CMS news via email and follow CMS on Twitter CMS Administrator @SeemaCMS, @CMSgov, and @CMSgovPress

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Statement by FDA Commissioner Scott Gottlieb, M.D., on the formation of a new work group to develop focused drug importation policy options to address access challenges related to certain sole-source medicines with limited patient availability, but no blocking patents or exclusivities - FDA Press Releases

FDA forms work group on drug importation policy options to address certain patient access challenges

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Streptomyces qaidamensis sp. nov., isolated from sand in the Qaidam Basin, China - Journal of Antibiotics

Streptomyces qaidamensis sp. nov., isolated from sand in the Qaidam Basin, China

<i>Streptomyces qaidamensis</i> sp. nov., isolated from sand in the Qaidam Basin, China, Published online: 19 July 2018; doi:10.1038/s41429-018-0080-9

Streptomyces qaidamensis sp. nov., isolated from sand in the Qaidam Basin, China

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Forthcoming Issues - Geriatrics

Alzheimer's and Other Dementias

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Contents - Geriatrics

Michael L. Malone and Kevin Biese

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Contributors - Geriatrics

MICHAEL L. MALONE, MD

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Copyright - Geriatrics

ELSEVIER

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Care for the Older Adult in the Emergency Department - Geriatrics

CLINICS IN GERIATRIC MEDICINE

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Delirium and Dementia - Geriatrics

Approximately 35% to 37% of older emergency department (ED) patients will have delirium or dementia, which can negatively affect safe and appropriate clinical care. This article describes the epidemiology of delirium and dementia in the ED and how it affects clinical care and patient outcomes. Screening for delirium and dementia in the context of the busy ED environment, as well as their diagnostic evaluation and management, is discussed.

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Care of Geriatric Patients with Advanced Illnesses and End-of-Life Needs in the Emergency Department - Geriatrics

Older patients with advanced illness are presenting more frequently to emergency departments (EDs). These patients have complex needs, which challenge busy EDs tuned to provide emergent, life-sustaining interventions, and rapid dispositions. This article outlines communication skills to assess patient goals so that the ED provider can create a care plan that matches level of medical intervention with patient wishes. Furthermore, this article outlines symptom-based care for the actively dying geriatric patient in the ED, specifically, acute pain, dyspnea, terminal delirium, secretions, dry mouth, fever, and bereavement.

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Communication Strategies for Better Care of Older Individuals in the Emergency Department - Geriatrics

The need for teamwork and communication among emergency department staff is central to excellent health care and of particular importance for the complex older adult population. Communication can decrease error, enhance safety, and improve throughput. Communication strategies both among multiple health care professionals, and between professionals and family and/or patients can improve care for older adults in the unique emergency department environment.

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Older Adults in the Emergency Department with Frailty - Geriatrics

In the emergency department (ED), frailty represents the vulnerability of an individual because of their underlying health status. An older patient can be identified as frail by using a frailty index, the Clinical Frailty Scale, a frailty phenotype, or a screening measure such as the Identification of Seniors at Risk (ISAR). In the ED, the frail older person should have an interdisciplinary assessment, a thoughtful review of their medications, a screen for other geriatric syndromes, and a care plan that addresses the individual’s needs, includes the patient’s goals and preferences, and follows the patient beyond the ED.

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Older Adult Falls in Emergency Medicine—A Sentinel Event - Geriatrics

Standing-level falls represent the most frequent cause of trauma-related death in older adults and a common emergency department presentation. However, these patients rarely receive guideline-directed screening and interventions during or following an episode of care. Reducing injurious falls in an aging society begins with prehospital evaluations and continues through risk assessments and interventions that occur after emergency department care. Although obstacles to emergency department-initiated, evidence-based older adult fall reduction strategies include the absence of a compelling emergency medicine evidence basis, innovations underway include validation of screening instruments and incorporation of contemporary technology like smart phones to improve fall detection rates.

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H-E-B Voluntarily Issues Recall Two Variety Packs of Creamy Creations Ice Creams and Sherbets in 3-Ounce Cups Recalled due to Broken Metal in Processing Equipment - FDA Safety Alerts & Drug Recalls

H-E-B is voluntarily issuing a recall for two variety packs of Creamy Creations ice cream and sherbets in 3-ounce cups due to broken metal found in processing equipment during routine maintenance. The potentially affected products were distributed only to H-E-B stores in Texas. Please note, the product was not distributed to the Houston area or Mexico.

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Portland French Bakery Issues Allergy Alert on Undeclared Soy in Seattle Sourdough Pub Buns and Franz Premium Pub Buns - FDA Safety Alerts & Drug Recalls

Portland French Bakery of Portland, OR is recalling 26,635 units of Seattle Sourdough Pub Bun 6pk and 8,022 units of Franz Premium Pub Buns 12pk, because it may contain undeclared SOY. People who have an allergy or severe sensitivity to soy 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 delivery at the Brookings Institution on the release of the FDA’s Biosimilars Action Plan - FDA Press Releases

FDA releases Biosimilars Action Plan to address competition and affordability for biologics and biosimilar products.

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FDA approves first cancer drug through new oncology review pilot that enables greater development efficiency - FDA Press Releases

FDA approves first cancer drug through new oncology review pilot that enables greater development efficiency

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Hy-Vee Voluntarily Recalls Spring Pasta Salad Due to Reported Illnesses - FDA Safety Alerts & Drug Recalls

WEST DES MOINES, Iowa (July 17, 2018) — Hy-Vee, Inc., based in West Des Moines, Iowa, is voluntarily recalling its Hy-Vee Spring Pasta Salad due to the potential that it may be contaminated with Salmonella. The potential for contamination was brought to Hy-Vee’s attention last night when approximately 20 illnesses in Minnesota, South Dakota, Nebraska and Iowa were potentially linked back to customers consuming the salad. The voluntary recall includes Hy-Vee Spring Pasta Salads in both 1 pound (16 oz.) and 3 pound (48 oz.) containers produced between June 1, 2018, and July 13, 2018, and available from the deli service case.

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New York-based food processors agree to stop food preparation operations due to food safety violations - FDA Press Releases

New York-based food processors agree to stop food preparation operations due to food safety violations

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Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets - FDA Safety Alerts & Drug Recalls

Teva Pharmaceuticals USA today confirmed a voluntary recall to the consumer / user level of 29 lots of single and 51 lots of combination valsartan medicines distributed under the Actavis label in the U.S. due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceutical. The impurity detected in the API is N- nitrosodimethylamine (NDMA), which 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 as per International Agency for Research on Cancer (IARC) classification.

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Statement from FDA Commissioner Scott Gottlieb, M.D. on new efforts to empower consumers by advancing access to nonprescription drugs - FDA Press Releases

FDA describes innovative approaches to increase access to a broader selection of nonprescription drug products for consumers

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Quinomycins H1 and H2, new cytotoxic antibiotics from Streptomyces sp. RAL404 - Journal of Antibiotics

Quinomycins H1 and H2, new cytotoxic antibiotics from Streptomyces sp. RAL404

Quinomycins H1 and H2, new cytotoxic antibiotics from <i>Streptomyces</i> sp. RAL404, Published online: 17 July 2018; doi:10.1038/s41429-018-0083-6

Quinomycins H1 and H2, new cytotoxic antibiotics from Streptomyces sp. RAL404

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Additional α-glucosidase inhibitors from Malbranchea flavorosea (Leotiomycetes, Ascomycota) - Journal of Antibiotics

Additional α-glucosidase inhibitors from Malbranchea flavorosea (Leotiomycetes, Ascomycota)

Additional α-glucosidase inhibitors from <i>Malbranchea flavorosea</i> (Leotiomycetes, Ascomycota), Published online: 17 July 2018; doi:10.1038/s41429-018-0075-6

Additional α-glucosidase inhibitors from Malbranchea flavorosea (Leotiomycetes, Ascomycota)

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The PictSweet Company Recalls 12 Ounce Steam’ables Baby Brussel Sprouts for Undeclared Milk and Soy Allergens - FDA Safety Alerts & Drug Recalls

Bells, TN – The Pictsweet Company has recalled 960 cases of Pictsweet Farms 12-ounce Steam’ables Baby Brussels Sprouts because they may contain undeclared milk and soy allergens. People who have an allergy or severe sensitivity to milk or soy may run the risk of serious allergic reaction if they consume this product.

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ALDI Voluntarily Recalls AnnaSea Wasabi Ahi Poke Hawaiian Poke Kits and Limu Ahi Poke Hawaiian Poke Kits Due to Storage at Incorrect Temperature in Area Store - FDA Safety Alerts & Drug Recalls

Batavia, Ill. Uuly 14, 2018) -ALDI has voluntarily recalled AnnaSea Wasabi Ahi Poke Hawaiian Poke Kits and Limu Ahi Poke Hawaiian Poke Kits sold at one retail store location in North Carolina. While the products are required to remain at frozen temperatures to ensure safety, this store location displayed and sold the products from the cooler section. Because storing the products at temperatures above freezing prior to consumption can render the products unsafe for consumption, ALDI is recalling these items.

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Major Pharmaceuticals Issues Voluntary Nationwide Recall of Valsartan Due to The Potential Presence of a Probable Carcinogen (NDMA) - FDA Safety Alerts & Drug Recalls

As a precautionary measure, the distribution firm, Major Pharmaceuticals, is issuing a nationwide voluntary recall of all lots within expiry of Valsartan which were supplied by Teva Pharmaceuticals and labeled as Major Pharmaceuticals.

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Utz Quality Foods Issues Allergy Alert on Undeclared Soy in Utz® Carolina Style Barbeque Potato Chips - FDA Safety Alerts & Drug Recalls

Utz® Quality Foods, LLC., is voluntarily recalling select expiration dates of Utz® Carolina Style Barbeque Potato Chips due to undeclared soy allergen. This recall was initiated after learning a certain number of packages were mislabeled. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.

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Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products - FDA Safety Alerts & Drug Recalls

Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level. This product recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. -- that is used in the manufacture of the subject product lots. This impurity has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.

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Water Pik, Inc. Recalls Sonic-Fusion® Flossing Toothbrush Product for Possible Health Risk - FDA Safety Alerts & Drug Recalls

Water Pik, Inc. is voluntarily recalling its Sonic-Fusion® flossing toothbrush because the charging base may overheat with localized melting and sparking, possibly causing fire, shock or burns. Water Pik, Inc. has received consumer reports of product malfunctioning in the U.S. The recall is applicable only to Sonic-Fusion® products. All other Waterpik® brand flossers and toothbrushes are not affected.

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FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity - FDA Press Releases

FDA is alerting the public about a voluntary recall of several drug products containing valsartan, used to treat high blood pressure and heart failure

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Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion Reactions - FDA Safety Alerts & Drug Recalls

Hospira, Inc., a Pfizer company, is voluntarily recalling 8 lots of Hospira’s Daptomycin for Injection 500 mg, Lyophilized Powder For Solution, Single Dose Vial (NDC 0409-0106-01) to the Hospital/Retail level. The product is being recalled due to adverse event reports indicative of infusion reactions.

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FDA approves the first drug with an indication for treatment of smallpox - FDA Press Releases

FDA today approved TPOXX (tecovirimat), the first drug with an indication for treatment of smallpox.

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AZ Firm Issues Voluntary Product Recall Due to Undeclared Peanuts in Superfood Salad - FDA Safety Alerts & Drug Recalls

Papa John’s Salads and Produce of Tolleson, AZ is voluntarily recalling 148 units of the Superfood Salads due to misbranding and undeclared peanuts. The product contains peanuts which are not declared on the product label as packages of peanuts were mistakenly included in the kits instead of cashews.

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FDA warns of imposters sending consumers fake warning letters - FDA Press Releases

FDA is warning consumers about criminals forging FDA warning letters to target individuals who tried to purchase medicines online or over the phone.

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Statement by FDA Commissioner Scott Gottlieb, M.D., on formation of a new drug shortages task force and FDA’s efforts to advance long-term solutions to prevent shortages - FDA Press Releases

FDA Commissioner Scott Gottlieb, M.D., on new drug shortages task force and work towards long-term solutions to prevent shortages

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FDA expands its support for states to advance implementation of produce safety activities - FDA Press Releases

FDA expands its support for states to advance implementation of produce safety activities

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MyNicNaxs, LLC Issues Voluntary Nationwide Recall of Various Dietary Supplements Due to Undeclared Active Pharmaceutical Ingredient (API) - FDA Safety Alerts & Drug Recalls

MyNicNaxs, LLC, Deltona, FL is voluntarily recalling all lots of dietary supplements distributed nationwide to the consumer level. The products have been found to contain undeclared active pharmaceutical ingredients (API). The presence of Sildenafil, Sibutramine, Diclofenac and/or Phenolphthalein in the dietary supplements renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. These products were distributed from January 2013, to December 2017, though our website https://ift.tt/2N6VEUF. The undeclared drug ingredients found in these products may pose serious health risks because consumers with underlying medical issues may take them without knowing that they can cause serious harm or interact in dangerous ways with other drugs they may be taking. API found in FDA samples include the following:

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Statement from FDA Commissioner Scott Gottlieb, M.D. on agency’s efforts to advance development of gene therapies - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D. on agency’s efforts to advance development of gene therapies, including three disease specific draft guidances

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Federal judge enters consent decree against Minnesota dairy farm for drug residue violations - FDA Press Releases

Federal judge enters consent decree against Minnesota dairy farm for drug residue violations

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FDA updates warnings for fluoroquinolone antibiotics on risks of mental health and low blood sugar adverse reactions - FDA Press Releases

FDA is requiring safety labeling changes for fluoroquinolones to strengthen the warnings about the risks of mental health side effects and serious blood sugar disturbances.

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FDA takes action to support American military personnel by granting an authorization for freeze-dried plasma product to enable broader access while the agency works toward approval of the product - FDA Press Releases

FDA granted an EUA to DOD to enable the emergency use of Pathogen-Reduced Leukocyte-Depleted Freeze-Dried Plasma (referred to as French FDP).

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Statement by FDA Commissioner Scott Gottlieb, M.D., on balancing access to appropriate treatment for patients with chronic and end-of-life pain with need to take steps to stem misuse and abuse of opioids - FDA Press Releases

FDA Commissioner statement on balancing access to appropriate treatment for patients with chronic and end-of-life pain with need to take steps to stem opioid misuse and abuse.

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Pseudomonas Aeruginosa Bacteria Found In Saje Splish Splash Gentle Baby Wash - FDA Safety Alerts & Drug Recalls

Saje Natural Wellness is warning customers not to use Splish Splash Gentle Baby Wash, 8.5 fl. oz. and 1.7 fl. oz. (found in the Wee and Well Gentle Baby Care Kit) as it may contain the bacteria Pseudomonas aeruginosa. Pseudomonas aeruginosa is an opportunistic pathogen that causes infection and results in bacteria in the blood, particularly in individuals with compromised immune systems.

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Radagast Pet Food, Inc. Voluntarily Recalls Three Lots of Rad Cat Raw Diet Free-Range Chicken Recipe and One Lot of Pasture-Raised Venison Recipe Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Radagast Pet Food, Inc. of Portland, OR is recalling three lots of Rad Cat Raw Diet Free-Range Chicken Recipe because testing results indicate they have the potential to be contaminated with Listeria monocytogenes. The Company is also recalling one lot of Rad Cat Raw Diet Pasture-Raised Venison Recipe because testing results indicate it has the potential to be contaminated with Shiga Toxin producing E. coli O121. This recall is being conducted out of an abundance of caution. Due to Radagast Pet Food’s commitment to food safety and quality, The Company is conducting this voluntary recall.

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LL’S Magnetic Clay Inc. Expands Allergy Alert On Undeclared Allergens In Prescript-Assist Dietary Supplement To All Lots - FDA Safety Alerts & Drug Recalls

LL’s Magnetic Clay, Inc. of Austin, Texas is recalling all lots of Prescript-Assist (still within expiration date), a dietary supplement it marketed until late 2017, because of its potential to contain undeclared allergens, including almonds, crustaceans, milk, casein, eggs, and peanuts. People who have an allergy or severe sensitivity to these specific types of allergens run the risk of serious or life-threatening allergic reaction if they consume these products.

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Dolyemycins A and B, two novel cyclopeptides isolated from Streptomyces griseus subsp. griseus HYS31 - Journal of Antibiotics

Dolyemycins A and B, two novel cyclopeptides isolated from Streptomyces griseus subsp. griseus HYS31

Dolyemycins A and B, two novel cyclopeptides isolated from <i>Streptomyces griseus</i> subsp. <i>griseus</i> HYS31, Published online: 06 July 2018; doi:10.1038/s41429-018-0071-x

Dolyemycins A and B, two novel cyclopeptides isolated from Streptomyces griseus subsp. griseus HYS31

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Identification of a novel bacteriocin-like protein and structural gene from Rhodococcus erythropolis JCM 2895, using suppression-subtractive hybridization - Journal of Antibiotics

Identification of a novel bacteriocin-like protein and structural gene from Rhodococcus erythropolis JCM 2895, using suppression-subtractive hybridization

Identification of a novel bacteriocin-like protein and structural gene from <i>Rhodococcus erythropolis</i> JCM 2895, using suppression-subtractive hybridization, Published online: 06 July 2018; doi:10.1038/s41429-018-0078-3

Identification of a novel bacteriocin-like protein and structural gene from Rhodococcus erythropolis JCM 2895, using suppression-subtractive hybridization

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Peniazaphilin A, a new azaphilone derivative produced by Penicillium sp. CPCC 400786 - Journal of Antibiotics

Peniazaphilin A, a new azaphilone derivative produced by Penicillium sp. CPCC 400786

Peniazaphilin A, a new azaphilone derivative produced by <i>Penicillium</i> sp. CPCC 400786, Published online: 05 July 2018; doi:10.1038/s41429-018-0077-4

Peniazaphilin A, a new azaphilone derivative produced by Penicillium sp. CPCC 400786

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Asperitaconic acids A–C, antibacterial itaconic acid derivatives produced by a marine-derived fungus of the genus Aspergillus - Journal of Antibiotics

Asperitaconic acids A–C, antibacterial itaconic acid derivatives produced by a marine-derived fungus of the genus Aspergillus

Asperitaconic acids A–C, antibacterial itaconic acid derivatives produced by a marine-derived fungus of the genus <i>Aspergillus</i>, Published online: 04 July 2018; doi:10.1038/s41429-018-0079-2

Asperitaconic acids A–C, antibacterial itaconic acid derivatives produced by a marine-derived fungus of the genus Aspergillus

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Engineered production of kitasetalic acid, a new tetrahydro-β-carboline with the ability to suppress glucose-regulated protein synthesis - Journal of Antibiotics

Engineered production of kitasetalic acid, a new tetrahydro-β-carboline with the ability to suppress glucose-regulated protein synthesis

Engineered production of kitasetalic acid, a new tetrahydro-β-carboline with the ability to suppress glucose-regulated protein synthesis, Published online: 04 July 2018; doi:10.1038/s41429-018-0074-7

Engineered production of kitasetalic acid, a new tetrahydro-β-carboline with the ability to suppress glucose-regulated protein synthesis

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Discovery of hybrids of indolin-2-one and nitroimidazole as potent inhibitors against drug-resistant bacteria - Journal of Antibiotics

Discovery of hybrids of indolin-2-one and nitroimidazole as potent inhibitors against drug-resistant bacteria

Discovery of hybrids of indolin-2-one and nitroimidazole as potent inhibitors against drug-resistant bacteria, Published online: 03 July 2018; doi:10.1038/s41429-018-0076-5

Discovery of hybrids of indolin-2-one and nitroimidazole as potent inhibitors against drug-resistant bacteria

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United States Bakery Issues Allergy Alert On Undeclared Milk In Naked Bread Hamburger Buns - FDA Safety Alerts & Drug Recalls

United States Bakery of Portland, Oregon is recalling Naked Bread Hamburger Buns #NothingToHide, 8 pack, affected lot codes F6 Best By June 16th, 2018 through July 16th 2018, because it 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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May Flower International Inc. Issues a Allergy Alert on Undeclared Milk Allergens in “3+2 Soda Crackers” - FDA Safety Alerts & Drug Recalls

May Flower International Inc. of 5672 49th Place, Maspeth, NY, is recalling its 4.4 ounce packages of “3+2 Soda Crackers” because they may contain undeclared milk allergens. Consumers who are allergic to milk allergens may run the risk of serious or life threatening allergic reactions if they consume this product.

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Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner for Foods and Veterinary Medicine Steven Ostroff, M.D., on the ongoing risk of salmonella in kratom products - FDA Press Releases

FDA statement on the ongoing risk of salmonella in kratom products

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Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule - FDA Safety Alerts & Drug Recalls

Blissful Remedies., is voluntarily recalling only Lot No.: 112710 with expiration 03/2019 found embedded on the top of package of kratom ( mitragyn a speciosa) powder products, it manufactured, processed, packed, and/or held, between “March 1, 2018” to “April 30, 2018” to the consumer level. The products have been found by the U.S. Food and Drug Administration (“FDA”) via sample testing to have salmonella contamination. Blissful Remedies has not received reports of adverse events related to this recall. In lieu of such FDA findings the company has implemented standard operating procedures and sterilization processes in accordance to FDA guidelines.

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Fagron Sterile Services Issues Voluntary Nationwide Recall of Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL and Neostigmine Methylsulfate 1mg/mL, 3mg per 3mL, in a 5mL syringe Due to Mislabeling - FDA Safety Alerts & Drug Recalls

Fagron Sterile Services is voluntarily recalling two (2) lots of Neostigmine Methylsulfate 5mL syringes to the user/hospital/clinic level. The specified product lots are being recalled because of a confirmed customer complaint that some syringe units containing Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL are incorrectly labelled as Neostigmine Methylsulfate 1mg/mL, 3mg per 3mL. Secondary packages are properly labelled as Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL.

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Allergy Alert Issued in Midwest Whole Foods Market Stores for Undeclared Soy in Oatmeal Raisin Cookies - FDA Safety Alerts & Drug Recalls

Whole Foods Market is voluntarily recalling Whole Foods Market brand oatmeal raisin cookies from stores in eight states because the products contained soy flour that was not listed on the product label. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.

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