Monday, December 31, 2018

Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 80 Lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP, Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity - FDA Safety Alerts & Drug Recalls

Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), 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. To date, Aurobindo Pharma USA, Inc. has not received any reports of adverse events related to this recall.

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Wednesday, December 26, 2018

Apio Inc. Expands Voluntary Recall of Eat Smart Salad Shake Ups Single-Serve Bowls - FDA Safety Alerts & Drug Recalls

Apio Inc. of Guadalupe, California is expanding a voluntary recall of Eat Smart Salad Shake Ups single-serve bowls. The recall comes after the Canadian Food Inspection Agency (CFIA) informed the company that another random sample of Eat Smart Salad Shake Ups Sweet Kale/Chou Frise Doux 156 gr. single-serve bowls (5.5oz) with Best Before Date of Dec 29, 2018, Lot 112 346, tested positive for 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.

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Monday, December 24, 2018

Columbia River Natural Pet Foods Inc. Voluntarily Expands Recall to Include Cow Pie and Chicken & Vegetables Fresh Frozen Meats for Dogs and Cats Due to Possible Health Risk - FDA Safety Alerts & Drug Recalls

Columbia River Natural Pet Foods of Vancouver, WA is voluntarily expanding their current recall to include additional products: 261 packages of Cow Pie Lot # 72618 and 82 packages of Chicken & Vegetables Lot# 111518 fresh frozen meats for dogs and cats, produced in July 2018 and November 2018, due to their potential to be contaminated with Salmonella and Listeria monocytogenes

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Friday, December 21, 2018

Funky Chunky, Llc Issues Allergy Alert on Undeclared Almond and Cashew Tree-Nut in 10 Oz. Nutty Choco Pop Found in Chocolate Popcorn Gift Box, Holiday Crowd Pleaser and Crowd Pleaser Gifts - FDA Safety Alerts & Drug Recalls

Funky Chunky, LLC of Eden Prairie, MN is recalling 10 oz Nutty Choco Pop Gift Box, 50 oz. Holiday Crowd Pleaser and 50 oz. Crowd Pleaser, because it may contain undeclared Almond and Cashew Tree Nut. People who have an allergy or severe sensitivity to Almonds and Cashews run the risk of serious or life-threatening allergic reaction if they consume these products.

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FDA permits marketing of a diagnostic test to aid in measuring nutrients in breast milk - FDA Press Releases

The FDA authorized use of a new test that measures nutrients in breast milk providing healthcare professionals with tool to aid in the nutritional management of newborns.

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FDA approves new treatment for adult patients with rare, life-threatening blood disease - FDA Press Releases

The FDA approved Ultomiris (ravulizumab) injection for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare and life-threatening blood disease.

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FDA approves first treatment for rare blood disease - FDA Press Releases

The FDA approved Elzonris (tagraxofusp-erzs) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients, two years of age and older.

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Thursday, December 20, 2018

Inspired Organics Issues Voluntary Recall of Organic Nut & Seed Butters Due to Potential Health Risk - FDA Safety Alerts & Drug Recalls

Inspired Organics, LLC has issued a voluntary recall of Organic Almond, Peanut, and Tahini Butters 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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Statement from FDA Commissioner Scott Gottlieb, M.D., on signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compounds - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., on signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compounds

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Terrific Care, LLC. / Medex Supply Dist, Inc. issues Nationwide Recall of CoaguChek Test Strips - FDA Safety Alerts & Drug Recalls

On 12/19/2018, Terrific Care, LLC. / Medex Supply Dist, Inc. initiated a nationwide recall of Roche CoaguChek test strips distributed directly to U.S. consumers by Terrific Care, LLC. / Medex Supply Dist, Inc. The products have been found to inaccurately report high INR test results.

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Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP - FDA Safety Alerts & Drug Recalls

Torrent Pharmaceuticals Limited is voluntarily recalling 2 lots of Losartan potassium tablets, USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The impurity detected in the API is N-nitrosodiethylamine (NDEA), 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 steps to strengthen the long-term safety oversight of the Essure device following discontinuation of its U.S. sales - FDA Press Releases

The FDA provides update on Essure postmarket review study as company prepares to halt sales of the device on December 31.

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FDA warns about safety risks of teething necklaces, bracelets to relieve teething pain or to provide sensory stimulation - FDA Press Releases

FDA alerted parents, caregivers and health care providers to the safety risks that jewelry used for relieving teething pain pose for children.

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FDA sends warning to company for marketing dangerous unapproved stem cell products that put patients at risk and puts other stem cell firms, providers on notice - FDA Press Releases

FDA sends warning letter to Genetech, Inc. and letters to other companies to reiterate the FDA’s compliance and enforcement policy regarding stem cells.

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Wednesday, December 19, 2018

Wegmans Issues Voluntary Recall of Fresh Cauliflower Rice, Veggie/Cauliflower Rice Blend and Stir-Fry Mix with Cauliflower - FDA Safety Alerts & Drug Recalls

Rochester, NY – Wegmans Food Markets, Inc. has issued a voluntary recall of fresh Cauliflower Rice, Veggie Cauliflower Rice Blend and Stir-Fry Mix with Cauliflower, sold in the produce department between 12/7/18 and 12/18/18, because it may be contaminated with Escherichia coli O157:H7 bacteria (E. Coli O157:H7). E. coli O157:H7 causes a diarrheal illness often with bloody stools. Although most healthy adults can recover completely within a week, some people can develop a form of kidney failure called Hemolytic Uremic Syndrome (HUS). HUS is most likely to occur in young children and the elderly. The condition can lead to serious kidney damage and even death.

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Tuesday, December 18, 2018

Medtronic Announces Worldwide Voluntary Field Corrective Action; Company Issues Software Update for Puritan Bennett™ 980 (Pb980) Ventilator Series - FDA Safety Alerts & Drug Recalls

Medtronic (NYSE:MDT) is notifying customers worldwide of a voluntary field corrective action for its Puritan Bennett™ 980 (PB980) ventilator series. Medtronic initiated this field action on September 19, 2018.

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Statement from FDA Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on new steps to promote innovations in medical devices that help advance patient safety - FDA Press Releases

FDA announces steps being taken on two medical device programs: finalizing guidance on the Breakthrough Device Program and announcing plans for a new Safer Technologies Program (STeP).

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Statement from FDA Commissioner Scott Gottlieb, M.D. on the FDA’s 2017 report on declining sales/distribution of antimicrobial drugs for food animals, a reflection of improved antimicrobial stewardship - FDA Press Releases

FDA’s 2017 report of sales/distribution data for antimicrobial drugs for food animals showed a continued decline in sales, a reflection of improved antimicrobial stewardship

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Two novel quinomycins discovered by UPLC-MS from Stretomyces sp. HCCB11876 - Journal of Antibiotics

Two novel quinomycins discovered by UPLC-MS from Stretomyces sp. HCCB11876

Two novel quinomycins discovered by UPLC-MS from Stretomyces sp. HCCB11876, Published online: 18 December 2018; doi:10.1038/s41429-018-0132-1

Two novel quinomycins discovered by UPLC-MS from Stretomyces sp. HCCB11876

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Monday, December 17, 2018

Adam Bros. Farming, Inc. Recalls Red and Green Leaf Lettuce and Cauliflower Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Adam Bros. Farming, Inc. of Santa Maria, California is recalling red leaf lettuce, green leaf lettuce and cauliflower harvested on November 27 through 30, 2018 out of an abundance of caution, because it may be contaminated with Escherichia coli O157:H7 bacteria (E. Coli O157:H7).

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Atherstone Foods Inc Issues Allergy Alert on Undeclared Soy in “Greens and Grains Hummus and Quinoa Tabouleh Wrap” - FDA Safety Alerts & Drug Recalls

ATHERSTONE FOODS INC of Richmond, CA is recalling 14.6 ounce (414g) Greens and Grains Hummus and Quinoa Tabouleh Wrap, 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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Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits Containing Recalled Sodium Chloride Injection, USP, 0.9% Due to Latex Hazard - FDA Safety Alerts & Drug Recalls

Torrance, CA, Asclemed USA Inc is voluntarily recalling 20 lots of Dyural-40 and 61 lots of Dyural-80, to the user level. The products include recalled Sodium Chloride, USP, 0.9% manufactured by Fresenius Kabi, which has been recalled due to product labeling incorrectly stating stoppers do not contain latex.

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Michigan-based food manufacturer agrees to stop operations after repeated food safety violations - FDA Press Releases

Saranac Brand Foods, Inc. specialized in a variety of 35 different ready-to-eat foods, including prepared salads, dips, and sauces.

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Inspired Organics Issues Voluntary Recall of Organic Almond Butter Due to Potential Health Risk - FDA Safety Alerts & Drug Recalls

Inspired Organics, LLC has issued a voluntary recall of Organic Almond Butter 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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Sunday, December 16, 2018

Semisynthesis and antibacterial activities of nidulin derivatives - Journal of Antibiotics

Semisynthesis and antibacterial activities of nidulin derivatives

Semisynthesis and antibacterial activities of nidulin derivatives, Published online: 17 December 2018; doi:10.1038/s41429-018-0133-0

Semisynthesis and antibacterial activities of nidulin derivatives

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Spokane Produce Voluntarily Recalls Northwest Cuisine Creations and Fresh&Local Sandwiches and Green Leaf Lettuce Filets - FDA Safety Alerts & Drug Recalls

Spokane Produce Inc. of Spokane, WA initiates a voluntary recall of sandwiches containing green leaf lettuce and foodservice lettuce filets following notice of a produce industry ingredient recall by Adam Bros. Farming Inc. Sandwich products bearing the Northwest Cuisine Creations and Fresh&Local labels. These prod- ucts are recalled because they may be contaminated with Escherichia coli O157:H7 bacteria (E. Coli O157:H7). E. coli O157:H7 causes a diarrheal illness often with bloody stools. Although most healthy adults can recover completely within a week, some people can develop a form of kidney failure called Hemolytic Uremic Syndrome (HUS). HUS is most likely to occur in young children and the elderly. The condition can lead to serious kidney damage and even death

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Saturday, December 15, 2018

Apio, Inc. Voluntarily Recalls Five Skus of Eat Smart Single-Serve Salad Shake Ups™ - FDA Safety Alerts & Drug Recalls

Apio, Inc. of Guadalupe, California is voluntarily recalling five SKUs of Eat Smart® Single-Serve Salad Shake Ups™ (bowls). The recall comes after the Canadian Food Inspection Agency (CFIA) informed the company that one random sample of Eat Smart Single-Serve Salad Shake Ups Sweet Kale/Chou Frise Doux 156 gr. (5.5oz) with Best Before of Dec 14, 2018 tested positive for Listeria Monocytogenes. As a precautionary measure, we are recalling all products produced on the same day, same production line, as the one sample that tested positive by CFIA. At this time, we are not aware of any illnesses linked by health officials to this recall and no other products are affected by this recall.

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Thursday, December 13, 2018

Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner Frank Yiannas on new findings and updated consumer recommendations related to the romaine lettuce E. coli O157:H7 outbreak investigation - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner Frank Yiannas on new findings and updated consumer recommendations related to the romaine lettuce E. coli O157:H7 outbreak investigation

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Statement from FDA Commissioner Scott Gottlieb, M.D. and Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D., on efforts to modernize generic drug labels while maintaining the efficiency of generic development - FDA Press Releases

FDA announces withdrawal of the proposed rule, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products

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Wednesday, December 12, 2018

Del Monte Foods Announces Limited Recall of Canned Fiesta Corn Seasoned with Red & Green Peppers Due to Under Processing - FDA Safety Alerts & Drug Recalls

Del Monte Foods Inc. announced a recall of 64,242 cases of FIESTA CORN Seasoned with Red & Green Peppers due to under-processing. These deviations were part of the commercial sterilization process and could result in contamination by spoilage organisms or pathogens, which could lead to life-threatening illness if consumed. It is important to note that there have been no reports of illness associated with these products to date. No other production codes or products are affected by this recall.

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Kimberly-Clark Announces Voluntary Recall of U by Kotex® Sleek® Tampons, Regular Absorbency,Throughout U.S. and Canada - FDA Safety Alerts & Drug Recalls

Kimberly-Clark announced a voluntary product recall of its U by Kotex® Sleek® Tampons, Regular Absorbency, sold throughout the United States and Canada for a quality-related defect that could impact the performance of this product.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts to improve drug quality through vigilant oversight of data integrity and good manufacturing practice - FDA Press Releases

FDA releases guidance with recommendations for drug manufacturers regarding good manufacturing practices and data integrity

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Mannonerolidol, a new nerolidol mannoside from culture broth of Schizophyllum commune - Journal of Antibiotics

Mannonerolidol, a new nerolidol mannoside from culture broth of Schizophyllum commune

Mannonerolidol, a new nerolidol mannoside from culture broth of <i>Schizophyllum commune</i>, Published online: 12 December 2018; doi:10.1038/s41429-018-0130-3

Mannonerolidol, a new nerolidol mannoside from culture broth of Schizophyllum commune

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Bioactive secondary metabolites from an endophytic fungus Phoma sp. PF2 derived from Artemisia princeps Pamp. - Journal of Antibiotics

Bioactive secondary metabolites from an endophytic fungus Phoma sp. PF2 derived from Artemisia princeps Pamp.

Bioactive secondary metabolites from an endophytic fungus <i>Phoma</i> sp. PF2 derived from <i>Artemisia princeps</i> Pamp., Published online: 12 December 2018; doi:10.1038/s41429-018-0131-2

Bioactive secondary metabolites from an endophytic fungus Phoma sp. PF2 derived from Artemisia princeps Pamp.

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Tuesday, December 11, 2018

Moonstruck Chocolate Co. Issues Allergy Alert On Undeclared Hazelnuts In 4 Oz. Sea Salt Caramels Tumbled In Milk Chocolate - FDA Safety Alerts & Drug Recalls

Moonstruck Chocolate Company of Portland, Oregon is recalling 600/4 oz. bags of Sea Salt Caramels Tumbled In Milk Chocolate, because it may contain undeclared hazelnuts. People who have an allergy or severe sensitivity to hazelnuts run the risk of a serious or life-threatening allergic reaction if they consume this product.

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FDA warns API manufacturer involved in valsartan recall, provides information for patients taking these medications - FDA Press Releases

FDA update on the ongoing investigation into angiotensin II receptor blocker impurities, recalls and current findings.

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Inspired Organics Issues Voluntary Recall of Organic Sunflower Butter Due to Potential Health Risk - FDA Safety Alerts & Drug Recalls

Inspired Organics, LLC has issued a voluntary recall of Organic Sunflower Butter 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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Statement from FDA Commissioner Scott Gottlieb, M.D., on new actions advancing the agency’s biosimilars policy framework - FDA Press Releases

FDA announces new actions advancing the agency’s biosimilars policy framework

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Monday, December 10, 2018

Statement from Jeff Shuren, M.D., J.D., Director of the Center for Devices and Radiological Health, on updated safety communication about rates of duodenoscope contamination from preliminary postmarket data - FDA Press Releases

FDA provides updates to postmarketing studies that agency ordered three manufacturers of duodenoscopes to conduct to assess bacterial contamination of devices.

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FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs - FDA Press Releases

FDA clears a mobile medical application (app) to help increase retention (the amount of time a patient participates) in an outpatient treatment program for individuals with opioid use disorder

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The J.M. Smucker Company Issues Voluntary Recall of Specific Lots of - FDA Safety Alerts & Drug Recalls

The J.M. Smucker Company today announced a voluntary recall of specific lots of 9Lives® Protein Plus® wet, canned cat food due to possible low levels of thiamine (Vitamin B1). No illnesses related to this issue have been reported to date and the product is being recalled out of an abundance of caution.

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New tetrahydroquinoline and indoline compounds containing a hydroxy cyclopentenone, virantmycin B and C, produced by Streptomyces sp. AM-2504 - Journal of Antibiotics

New tetrahydroquinoline and indoline compounds containing a hydroxy cyclopentenone, virantmycin B and C, produced by Streptomyces sp. AM-2504

New tetrahydroquinoline and indoline compounds containing a hydroxy cyclopentenone, virantmycin B and C, produced by <i>Streptomyces</i> sp. AM-2504, Published online: 10 December 2018; doi:10.1038/s41429-018-0117-0

New tetrahydroquinoline and indoline compounds containing a hydroxy cyclopentenone, virantmycin B and C, produced by Streptomyces sp. AM-2504

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Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on new efforts to assure the quality of compounded drugs - FDA Press Releases

FDA releases guidance with recommendations for protecting patients from the risk of contaminated or substandard compounded products produced by outsourcing facilities.

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Simpotentin, a new potentiator of amphotericin B activity against Candida albicans, produced by Simplicillium minatense FKI-4981 - Journal of Antibiotics

Simpotentin, a new potentiator of amphotericin B activity against Candida albicans, produced by Simplicillium minatense FKI-4981

Simpotentin, a new potentiator of amphotericin B activity against <i>Candida albicans</i>, produced by <i>Simplicillium minatense</i> FKI-4981, Published online: 10 December 2018; doi:10.1038/s41429-018-0128-x

Simpotentin, a new potentiator of amphotericin B activity against Candida albicans, produced by Simplicillium minatense FKI-4981

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Friday, December 7, 2018

Fine Land Corp Issues Allergy Alert on Undeclared Milk Allergens in “Meiqili Durian Candy” - FDA Safety Alerts & Drug Recalls

Fine Land Corp is recalling it’s 12 ounce (340 g) Meiqili Durian Candy in plastic bag with clear window because it contains 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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Thursday, December 6, 2018

Accra Super Market Issues Allergy Alert On Undeclared Peanuts In 'Suya Barbecue Seasoning' - FDA Safety Alerts & Drug Recalls

Accra Super Market of Worcester MA, is recalling 0.53 lbs packages of "Suya Barbecue Seasoning" because it may contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume this product.

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Kroger Louisville Division Recalls Abound Chicken and Brown Rice Dog Food Because of Elevated Vitamin D Levels - FDA Safety Alerts & Drug Recalls

Following a recall by Sunshine Mills, Inc., the Kroger Louisville division announced it has removed from sale Abound Chicken & Brown Rice Recipe dog food produced by the supplier. The dog food was sold in one Kroger store located at 2440 Bardstown Road in Louisville, KY. Only Abound Chicken & Brown Rice Recipe dog food with the listed UPC numbers and Best by Dates are affected by this recall. The recall was initiated because the product had the potential to contain an elevated level of Vitamin D, which may cause renal failure.

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King Soopers and City Market Recalls Abound Chicken and Brown Rice Dog Food Because of Elevated Vitamin D Levels - FDA Safety Alerts & Drug Recalls

Following a recall by Sunshine Mills, Inc., King Soopers announced it has removed from sale Abound Chicken & Brown Rice Recipe dog food produced by Sunshine Mills, Inc. sold in King Soopers and City Market stores, located in Colorado, Utah, New Mexico and Wyoming. Only Abound Chicken & Brown Rice Recipe dog food with the listed UPC numbers and Best by Dates are affected by this recall. The recall was initiated because the product had the potential to contain an elevated level of Vitamin D, which may cause renal failure.

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Danone North America Issues Allergy Alert and Recall for Light & Fit Greek Crunch S’mores Flavor - FDA Safety Alerts & Drug Recalls

Danone North America is voluntarily recalling 3,521 cases of Light & Fit® Greek Crunch Nonfat Yogurt & Toppings S’Mores Flavor sold in the United States with an expiration date of December 30, 2018 and UPC of 36632 03825. It was discovered that some of the toppers sold on the product contain peanuts and are improperly labeled. 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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Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen - FDA Safety Alerts & Drug Recalls

Tris Pharma, Inc. has voluntarily recalled three (3) lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level. The recalled lots of the product have been found to potentially have higher concentrations of ibuprofen.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new strategic framework to advance use of real-world evidence to support development of drugs and biologics - FDA Press Releases

FDA releases new strategic framework to advance use of real-world evidence to support development of drugs and biologics

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Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new effort for developing and class labeling of in vitro companion diagnostics for classes of oncology therapeutic products - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new effort for developing and class labeling of vitro companion diagnostics for classes of oncology therapeutic products

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Country Flavor Inc Issues Alert on Undeclared Sulfites In "Best Taste Brand Dried Bamboo Shoot" - FDA Safety Alerts & Drug Recalls

Country Favor Inc. of Maspeth, New York is recalling its 12 ounce packages of "Best Taste Brand DRIED BAMBOO SHOOT" food treats because they contained undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.

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Wednesday, December 5, 2018

Columbia River Natural Pet Foods Inc. Recalls Cow Pie Fresh Frozen Meats for Dogs and Cats Because of Possible Listeria monocytogenes Health Risk - FDA Safety Alerts & Drug Recalls

Columbia River Natural Pet Foods of Vancouver, WA is voluntarily recalling 933 packages of Cow Pie fresh frozen meats for dogs and cats, produced in August 2017, because it has the potential to be contaminated with Listeria monocytogenes

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Tuesday, December 4, 2018

Chukar Cherries Expands Recall of Ultra Dark Chocolate Product Due to Undeclared Milk - FDA Safety Alerts & Drug Recalls

Chukar Cherries of Prosser, WA expands a recall on Ultra Dark Chocolate product 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 these products.

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Hiland Dairy Announces Voluntary Recall of Hiland Dairy Half-Gallon Whole Chocolate Milk - FDA Safety Alerts & Drug Recalls

Hiland Dairy is announcing a voluntary recall of half-gallon premium whole milk chocolate that is produced at the Kansas City, Missouri facility, over concerns the products may contain eggnog that could affect those individuals that have sensitivity to egg allergens. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume these products.

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

– Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within expiry. The 104 additional lots include 26 lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths), 51 lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg and 320 mg strengths), and 27 lots of Valsartan and Hydrochlorothiazide Tablets, USP (80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg and 320mg/25mg strengths).

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FDA takes new action to advance the development of reliable and beneficial genetic tests that can improve patient care - FDA Press Releases

FDA takes new action to advance the development of reliable and beneficial genetic tests that can improve patient care

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Sunday, December 2, 2018

Isolation of ketomycin from Actinomycetes as an inhibitor of 2D and 3D cancer cell invasion - Journal of Antibiotics

Isolation of ketomycin from Actinomycetes as an inhibitor of 2D and 3D cancer cell invasion

Isolation of ketomycin from <i>Actinomycetes</i> as an inhibitor of 2D and 3D cancer cell invasion, Published online: 03 December 2018; doi:10.1038/s41429-018-0129-9

Isolation of ketomycin from Actinomycetes as an inhibitor of 2D and 3D cancer cell invasion

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Friday, November 30, 2018

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

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

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

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

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

Fluorescence assay to predict activity of the glycopeptide antibiotics

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

Fluorescence assay to predict activity of the glycopeptide antibiotics

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Thursday, November 29, 2018

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

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

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

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

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

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

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Wednesday, November 28, 2018

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

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

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

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

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

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

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

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

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

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

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Tuesday, November 27, 2018

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Monday, November 26, 2018

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

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

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

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

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

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

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Acknowledgments - Journal of Antibiotics

Acknowledgments

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

Acknowledgments

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

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

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

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

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

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

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Saturday, November 24, 2018

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

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

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Friday, November 23, 2018

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

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

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Wednesday, November 21, 2018

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

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

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

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

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Tuesday, November 20, 2018

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Monday, November 19, 2018

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

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

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

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

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

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

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Sunday, November 18, 2018

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

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

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

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

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

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

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

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

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Saturday, November 17, 2018

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

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

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Friday, November 16, 2018

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Thursday, November 15, 2018

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

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

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

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

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Wednesday, November 14, 2018

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

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

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

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

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Tuesday, November 13, 2018

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

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

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

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

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

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

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Monday, November 12, 2018

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

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

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Friday, November 9, 2018

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Thursday, November 8, 2018

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

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

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

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

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

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

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

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

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

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

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Wednesday, November 7, 2018

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

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

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

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

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Tuesday, November 6, 2018

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

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

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Monday, November 5, 2018

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

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

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

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

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Saturday, November 3, 2018

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

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

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

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

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Friday, November 2, 2018

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Thursday, November 1, 2018

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

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

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

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

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

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

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

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

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

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

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

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

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Wednesday, October 31, 2018

Forthcoming Issues - Geriatrics

Falls Prevention

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Contents - Geriatrics

Fred A. Luchette and Robert D. Barraco

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Contributors - Geriatrics

FRED A. LUCHETTE, MD, MSc

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Copyright - Geriatrics

ELSEVIER

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Surgery and the Geriatric Patient - Geriatrics

CLINICS IN GERIATRIC MEDICINE

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Nuances of Surgical Care for the Elderly - Geriatrics

Unprecedented population growth, complex medical problems, and widespread use of anticoagulants: the perfect storm for the Silver Tsunami. Those aged 65 and over will number 98.2 million in the United States in the year 2060, with 19.7 million aged 85 and over.1 Arthritis, heart disease, cancer, pulmonary disease, and Alzheimer round out the top five health concerns in the elderly per the Centers for Disease Control and Prevention. However, the unspoken epidemic is that of frailty, with 44% of the elderly prefrail and 10% frail.

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Surgical Oncology and Geriatric Patients - Geriatrics

Geriatric medicine is a growing field filled with complicated patients who are susceptible to developing cancer. Surgical oncology is expanding while adapting to the increasing elderly population and creating novel treatment regimens for this group of patients. This article reviews surgical oncology in elderly patients and addresses surgical optimization, management of several cancer subtypes, surgical advances in minimally invasive surgery, and ethical considerations.

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FDA authorizes first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism - FDA Press Releases

FDA authorizes first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism

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Statement from FDA Commissioner Scott Gottlieb, M.D., on meetings with industry related to the agency’s ongoing policy commitment to firmly address rising epidemic rates in youth e-cigarette use - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., on meetings with industry related to the agency’s ongoing policy commitment to firmly address rising epidemic rates in youth e-cigarette use.

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Tuesday, October 30, 2018

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP 75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API) - FDA Safety Alerts & Drug Recalls

ScieGen Pharmaceuticals, Inc. is voluntarily recalling listed lots, within expiry, of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms to the consumer level. These products are being recalled due to the presence of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Irbesartan, USP manufactured by Aurobindo Pharma Limited. This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC)

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FDA takes action to stop the use of lead acetate in hair dyes - FDA Press Releases

FDA takes action to stop the use of lead acetate in hair dyes. FDA will no longer allow lead acetate to be used in certain hair coloring products based on data that demonstrate that there is no longer a reasonable certainty of no harm from the use of this color additive.

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Statement from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Anna Abram on the FDA’s new plan to advance plant, animal biotechnology innovation - FDA Press Releases

FDA announces new plan to advance the development of plant and animal biotechnology innovation

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Food Recall of Fit & Active Southwest Veggie Stuffed Sandwiches Due to Possible Listeria monocytogenes and Salmonella Contamination in Vegetables - FDA Safety Alerts & Drug Recalls

J&J Snack Foods Handheld Corp. of Holly Ridge, NC is voluntarily recalling two lots of Fit & Active Southwest Veggie Stuffed Sandwiches due to potential contamination with Listeria monocytogenes and Salmonella. Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

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Monday, October 29, 2018

Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of NDEA (NNitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API) - FDA Safety Alerts & Drug Recalls

Aurobindo Pharma Limited is voluntarily recalling 22 Batches of the drug substance Irbesartan due to the presence of an impurity, N-nitrosodiethylamine (NDEA). The impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC).

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Maribel’s Sweets Inc. Allergy Alert on Undeclared Milk Allergens in Chocolate Bars - FDA Safety Alerts & Drug Recalls

Maribel’s Sweets Inc. of Brooklyn, NY is recalling its 2.82oz MarieBelle Japanese Matcha Japanese Green Tea and White Chocolate Bar, container code 101619, Cacao Market by MarieBelle Rosemary Truffle Salt 60% Dark Chocolate Bar, all container codes, and the Cacao Market by MarieBelle Orange Peels 60% Dark Chocolate Bar, all container codes, 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., on the FDA’s new consideration of labeling for sesame allergies - FDA Press Releases

Food allergies have touched the lives of most of us. Thousands of Americans experience life-threatening, food-related reactions each year, and an estimated 20 people die from them annually. In some cases, such reactions occur despite a careful reading of packaged food labels by conscientious consumers. To me, that’s unacceptable. The FDA is committed to advancing our efforts to help ensure that Americans have access to the information they need about common allergens in packaged foods.

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Thursday, October 25, 2018

Curvulaide A, a bicyclic polyketide with anti-anaerobic bacteria activity from marine-derived Curvularia sp. - Journal of Antibiotics

Curvulaide A, a bicyclic polyketide with anti-anaerobic bacteria activity from marine-derived Curvularia sp.

Curvulaide A, a bicyclic polyketide with anti-anaerobic bacteria activity from marine-derived <i>Curvularia</i> sp., Published online: 26 October 2018; doi:10.1038/s41429-018-0110-7

Curvulaide A, a bicyclic polyketide with anti-anaerobic bacteria activity from marine-derived Curvularia sp.

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Urgent: Curry Spice Recall - FDA Safety Alerts & Drug Recalls

This voluntary recall has been initiated by UBC Food Distributors Inc, due to a high level of lead found in the product after testing was done by the Michigan Department of Agriculture & Rural Development, which found high traces of lead.

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Augmented antibacterial activity of ampicillin with silver nanoparticles against methicillin-resistant Staphylococcus aureus (MRSA) - Journal of Antibiotics

Augmented antibacterial activity of ampicillin with silver nanoparticles against methicillin-resistant Staphylococcus aureus (MRSA)

Augmented antibacterial activity of ampicillin with silver nanoparticles against methicillin-resistant <i>Staphylococcus aureus</i> (MRSA), Published online: 25 October 2018; doi:10.1038/s41429-018-0111-6

Augmented antibacterial activity of ampicillin with silver nanoparticles against methicillin-resistant Staphylococcus aureus (MRSA)

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Inhibition effect of flavophospholipol on conjugative transfer of the extended-spectrum β-lactamase and vanA genes - Journal of Antibiotics

Inhibition effect of flavophospholipol on conjugative transfer of the extended-spectrum β-lactamase and vanA genes

Inhibition effect of flavophospholipol on conjugative transfer of the extended-spectrum β-lactamase and <i>vanA</i> genes, Published online: 25 October 2018; doi:10.1038/s41429-018-0113-4

Inhibition effect of flavophospholipol on conjugative transfer of the extended-spectrum β-lactamase and vanA genes

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Wednesday, October 24, 2018

Shirley’s Cookie Company In. Issues Allergy Alert on Undeclared Peanuts in "Chocolate Whoopie Pie" - FDA Safety Alerts & Drug Recalls

Shirley’s Cookie Company Inc. of Claysburg, PA, is recalling its 16 ounce packages of "Chocolate Whoopie Pie" 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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FDA permits marketing of a diagnostic test to aid in the determination of menopausal status - FDA Press Releases

FDA permits marketing of a diagnostic test to aid in the determination of menopausal status

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Statement from FDA Commissioner Scott Gottlieb, M.D., on how new regulatory authorities will assist the agency in more forcefully addressing opioid crisis; included as part of the newly enacted Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act - FDA Press Releases

The SUPPORT Act grants FDA additional authorities to meaningfully advance efforts to combat the crisis of opioid addiction plaguing our nation.

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Sirob Imports, Inc. Issues Recall Due to Elevated Lead in Spices - FDA Safety Alerts & Drug Recalls

Sirob Imports, Inc of Lindenhurst, NY is recalling, Corrado, Orlando Imports, Nouri’s Syrian Bakery, Mediterranean Specialty Foods Brand and Butera Fruit Market Curry Powder because it contains elevated levels of lead.

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FDA approves new drug to treat influenza - FDA Press Releases

FDA approved Xofluza (baloxavir marboxil) to treat acute uncomplicated flu in patients 12 years old and older who have been symptomatic for less than 48 hours.

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G & C Raw, LLC is Expanding Recall to Include All Product Lots Manufactured from February 27, 2018 Through July 20, 2018, Because of Possible Listeria Monocytogenes Health Risk - FDA Safety Alerts & Drug Recalls

G & C Raw, of Versailles, OH is recalling all products lots manufactured from February 27, 2018 through July 20, 2018, as a precaution because they have the potential to be contaminated with Listeria monocytogenes

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Ala-geninthiocin, a new broad spectrum thiopeptide antibiotic, produced by a marine Streptomyces sp. ICN19 - Journal of Antibiotics

Ala-geninthiocin, a new broad spectrum thiopeptide antibiotic, produced by a marine Streptomyces sp. ICN19

Ala-geninthiocin, a new broad spectrum thiopeptide antibiotic, produced by a marine <i>Streptomyces</i> sp. ICN19, Published online: 24 October 2018; doi:10.1038/s41429-018-0115-2

Ala-geninthiocin, a new broad spectrum thiopeptide antibiotic, produced by a marine Streptomyces sp. ICN19

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Tuesday, October 23, 2018

Federal judge enters consent decree against Tennessee over-the-counter drug manufacturer - FDA Press Releases

A federal court orders a Tennessee-based company to stop selling over-the-counter (OTC) drug products

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FDA launches global operation to crack down on websites selling illegal, potentially dangerous drugs; including opioids - FDA Press Releases

FDA warns website networks as part of global crack down for selling illegal pharmaceuticals

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New Seasons Market Issues Allergy Alert on Undeclared Soy in Hot & Sour Broth - FDA Safety Alerts & Drug Recalls

New Seasons Market is recalling 193 jars of New Seasons Market Hot & Sour Broth because it contains 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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Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to advance new ways to increase the availability of naloxone as one means for reducing opioid overdose deaths - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to advance new ways to increase the availability of naloxone as one means for reducing opioid overdose deaths

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MS network-based screening for new antibiotics discovery - Journal of Antibiotics

MS network-based screening for new antibiotics discovery

MS network-based screening for new antibiotics discovery, Published online: 23 October 2018; doi:10.1038/s41429-018-0109-0

MS network-based screening for new antibiotics discovery

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Monday, October 22, 2018

Promise Pharmacy Issues Voluntary Nationwide Recall of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% Sterile Due to Small Particulate Floating in the Solution - FDA Safety Alerts & Drug Recalls

Promise Pharmacy is voluntarily recalling one lot of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% sterile, 3ml vials, to the patient consumer level. The product has been found to have unidentified small particulate floating in the solution.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s ongoing commitment to improving efficiency, transparency of tobacco product application review process as part of FDA’s comprehensive framework to reduce tobacco-related disease and death - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s ongoing commitment to improving efficiency, transparency of tobacco product application review process as part of FDA’s comprehensive framework to reduce tobacco-related disease and death.

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Friday, October 19, 2018

Working Cow Homemade, Inc. Expands Recall of Ice Cream Products Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Working Cow Homemade, Inc. of St. Petersburg, FL is expanding its voluntary recall to include all ice cream manufactured from August 29, 2017 – October 11, 2018, 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. This is an expansion of an earlier recall.

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Cedar’s Mediterranean Foods Issues Allergy Alert on Undeclared Soy in Cedar’s Chickpea Salad 8 oz. - FDA Safety Alerts & Drug Recalls

Cedar’s Mediterranean Foods, of Ward Hill, MA is voluntarily recalling Cedar’s Chickpea Salad 8 oz. because it may contain undeclared edamame (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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Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to help produce farmers, processors more effectively comply with food safety requirements - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to help produce farmers, fresh-cut produce processors more effectively comply with food safety requirements

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Thursday, October 18, 2018

Hy-Vee Voluntarily Recalls Several Meat and Potato Products - FDA Safety Alerts & Drug Recalls

Hy-Vee, Inc., based in West Des Moines, Iowa, is voluntarily recalling six of its meat and potato products across its eight-state region due to possible contamination with Salmonella and Listeria monocytogenes. The potential for contamination was discovered after Hy-Vee’s supplier, McCain Foods, announced it was recalling its caramelized mushrooms and fire-roasted tomatoes, which are ingredients that are used in six Hy-Vee products. To date, no illnesses have been reported in connection with these products.

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Trump Administration Launches “Winning on Reducing Food Waste” Initiative - FDA Press Releases

The U.S. Department of Agriculture (USDA), the U.S. Environmental Protection Agency (EPA), and the U.S. Food and Drug Administration (FDA) today announced the signing of a joint agency formal agreement under the "Winning on Reducing Food Waste" initiative.

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Stewart’s Shops Issues Allergy Alert on Undeclared Milk in Cranberry Apple Refresher - FDA Safety Alerts & Drug Recalls

Saratoga Springs, NY - Stewart’s Shops Corp. is recalling units of Stewart’s Shops brand Cranberry Apple Refresher 16 fluid oz. because the product may contain undeclared milk. People who have an allergy to milk run the risk of serious or life-threatening allergic reaction if they consume this product. Approximately 2,300 units of affected product were distributed in upstate New York and Southern Vermont.

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Wednesday, October 17, 2018

P. East Trading Corp. Issues Alert on Undeclared Sulfites In Fruits Du Sud Golden Seedless Raisins - FDA Safety Alerts & Drug Recalls

P. EAST TRADING CORP. of Bronx, NY is recalling Fruits Du Sud Golden Seedless Raisins (Lot No. FDS T499/18) 30 lbs Box, because they contain undeclared SULFITES. People who have a severe sensitivity to sulfites run the risk of serious or life-threatening reactions if they consume these products.

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SLR Food Distribution Inc. Issues Alert on Undeclared Sulfites in Sugar Melon Candy - FDA Safety Alerts & Drug Recalls

SLR Food Distribution Inc. of New Hyde Park, NY is recalling its 7.04oz package of SUGAR MELON CANDY / WAX GOURD because it contains undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.

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New Nan Fong Hong Trading Inc. Issues Allergy Alert on Undeclared Sulfites in Source Day Natural Treasures Dried Liquorice Slice - FDA Safety Alerts & Drug Recalls

New Nan Fong Hong Trading Inc. is recalling its 16 oz (454g) packages of Source Day Natural Treasures Dried Liquorice Slice because they contain undeclared sulfites. Consumers who are allergic to sulfite allergens run the risk of serious or life-threatening allergic reactions if they consume this product.

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Faribault Foods, Inc. Announces Voluntary Recall of a Limited Quantity of S&W Brand White Beans Due to the Presence of Undeclared (Sulfites) - FDA Safety Alerts & Drug Recalls

Faribault Foods, Inc. of Faribault, MN is recalling its 15 ounce S&W White Beans because it contains 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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Tuesday, October 16, 2018

Forthcoming Issues - Geriatrics

Surgery and the Geriatric Patient

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Contents - Geriatrics

John E. Morley

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Contributors - Geriatrics

JOHN E. MORLEY, MB, BCh

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Copyright - Geriatrics

ELSEVIER

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Alzheimer Disease and Other Dementias - Geriatrics

CLINICS IN GERIATRIC MEDICINE

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Patient-Centered Care and Cognitive Dysfunction - Geriatrics

Cognitive dysfunction is one of the most common conditions to plague older persons.1 Approximately 20% of persons over 70 years of age have dementia and another 20% have mild cognitive impairment. Physicians are not very good at recognizing older persons with cognitive impairment. This results in the patients following medical instructions poorly (eg, taking medicines improperly, inability to use inhalers or to measure glucose levels accurately). In addition, cognitively impaired older persons tend to continue to drive when it is dangerous and often continue to manage their own financial affairs.

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Screening for Cognitive Impairment in Geriatrics - Geriatrics

There are many instruments for screening cognitive impairment. The common tools for screening cognitive impairment are categorized into 4 groups (very brief, brief, self-administered, and test batteries) in geriatrics. There are some tests used for specific tests of 6 cognitive domains (learning and memory, language, executive function, complex attention, and social cognition) by following the DSM-V criteria. Different settings, stages, conditions, and specific people need some specific tools for screening cognitive impairment. It must be noted that there is some harm in screening for cognitive impairment in geriatrics.

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Clackamas Bakery Recalls Fred Meyer Bakery Angel Food Cake Bar Due to Undeclared Allergens - FDA Safety Alerts & Drug Recalls

Clackamas Bakery has recalled Fred Meyer Bakery Angel Food Cake Bar (12 oz.) sold in its retail stores because the product may contain milk and soy not listed on the label. Clackamas Bakery initiated the recall when it was discovered that the Fred Meyer Bakery Angel Food Cake Bar label had been incorrectly applied to packages of cornbread.

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FDA and DHS increase coordination of responses to medical device cybersecurity threats under new partnership; a part of the two agency’s broader effort to protect patient safety - FDA Press Releases

FDA and DHS announce partnership to address medical device cybersecurity threats

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Cyathane diterpenoids and drimane sesquiterpenoids with neurotrophic activity from cultures of the fungus Cyathus africanus - Journal of Antibiotics

Cyathane diterpenoids and drimane sesquiterpenoids with neurotrophic activity from cultures of the fungus Cyathus africanus

Cyathane diterpenoids and drimane sesquiterpenoids with neurotrophic activity from cultures of the fungus <i>Cyathus africanus</i>, Published online: 16 October 2018; doi:10.1038/s41429-018-0106-3

Cyathane diterpenoids and drimane sesquiterpenoids with neurotrophic activity from cultures of the fungus Cyathus africanus

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Monday, October 15, 2018

Feel Good Foods Inc Issues Allergy Alert on Undeclared Egg Product In “Vegetable Fried Rice” - FDA Safety Alerts & Drug Recalls

Feel Good Foods Inc. of Brooklyn, NY is recalling six lots of “Vegetable Fried Rice” frozen meals, UPC 00899039002129 because they may contain undeclared egg. People who have allergies to egg run the risk of serious or life-threatening allergic reaction if they consume these products.

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Fat Burners Zone Issues Voluntary Nationwide Recall of Zero Xtreme Due to Presence of Undeclared Sibutramine - FDA Safety Alerts & Drug Recalls

Fat Burners Zone is voluntarily recalling 1 lot of Zero Xtreme, capsules to the consumer level. FDA analysis has found Zero Xtreme to be tainted with sibutramine. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market due to safety concerns. The presence of Sibutramine in Zero Xtreme renders it an unapproved drug for which safety and efficacy has not been established and, therefore, subject to recall.

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Apollo Food International Inc Issues Allergy Alert on Undeclared Eggs In “Mini Roll” - FDA Safety Alerts & Drug Recalls

Apollo Food International Inc. of Long Island City, NY, is recalling its 2.469 ounce packages of “Mini Roll” food treats because they may contain undeclared eggs. Consumers who are allergic to eggs may run the risk of serious or life-threatening allergic reactions if they consume this product.

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Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to modernize drug development, improve efficiency and promote innovation of targeted therapies - FDA Press Releases

FDA issues two guidance documents to provide drug developers greater clarity and direction as they pursue the next generation of therapies and treatments for patients.

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Friday, October 12, 2018

FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy - FDA Press Releases

FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy

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Voluntary Recall of Limited Amounts of Nuts & Vanilla Protein Plant Shake - FDA Safety Alerts & Drug Recalls

Forager Project is recalling three dates of Nuts and Vanilla – Organic Plant Protein Shake because the product contains almond flour which is not declared on the label.

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Synthesis and evaluation of biological activity of benzoxaborole derivatives of azithromycin - Journal of Antibiotics

Synthesis and evaluation of biological activity of benzoxaborole derivatives of azithromycin

Synthesis and evaluation of biological activity of benzoxaborole derivatives of azithromycin, Published online: 12 October 2018; doi:10.1038/s41429-018-0107-2

Synthesis and evaluation of biological activity of benzoxaborole derivatives of azithromycin

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Thursday, October 11, 2018

Suicide in the Elderly - Geriatrics

Suicide in the elderly is a growing problem. The elderly population is increasing, and elderly patients have multiple issues that place them at higher risk of suicidality. These issues include physical illnesses, mental illness, loss of functional status, isolation, and family, financial, and social factors. Access to firearms is another significant risk factor, because elderly patients are more likely to use firearms in suicide attempts; interventions to reduce firearms mortality may save lives. Tackling the difficult problem of suicide in the elderly may require a multidisciplinary, community-based series of interventions.

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