Friday, September 28, 2018

FDA approves a new antibacterial drug to treat a serious lung disease using a novel pathway to spur innovation - FDA Press Releases

The FDA approved the first antibacterial drug under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD). LPAD was created by Congress to spur development of drugs targeting serious infections in limited patient populations with unmet need.

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FDA approves first treatment for advanced form of the second most common skin cancer - FDA Press Releases

FDA approves Libtayo (cemiplimab-rwlc) for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. This is the first FDA approval of a drug specifically for advanced CSCC.

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Palliative Care and Geriatric Surgery - Geriatrics

Although many seniors cite maintaining independence and a desire to die at home as health priorities, admission to the ICU and the use of invasive procedures are common near the end of life. Palliative care aims to relieve pain and other symptoms to maintain the highest quality of life for the longest period of time, but surgical patients are less likely to be referred to palliative care than patients with chronic medical conditions. Meeting the palliative care needs of elderly surgical patients requires early recognition, advance care planning, and multidisciplinary interventions that align patient goals with possible outcomes.

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Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label - FDA Safety Alerts & Drug Recalls

Endo International plc (NASDAQ: ENDP) today announced that one of its operating companies, Endo Pharmaceuticals Inc., is voluntarily recalling two lots of Robaxin® (methocarbamol tablets, USP) 750mg Tablets 100 Count Bottle pack to the consumer level. The products have been found to have incorrect daily dosing information on the label due to a labeling error which misstates the daily dose as "two to four tablets four times daily" rather than the correct dosage of "two tablets three times daily." (see picture below for location of incorrect text).

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FDA authorizes first next generation sequencing-based test to detect very low levels of remaining cancer cells in patients with acute lymphoblastic leukemia or multiple myeloma - FDA Press Releases

FDA authorizes first next generation sequencing-based test to detect very low levels of remaining cancer cells in patients with acute lymphoblastic leukemia or multiple myeloma

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Thursday, September 27, 2018

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

During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing (see Picture 1, No. 2 Pin Cap and Cover) may slide and potentially expose the connection wire. In some instances, this may cause the wire to be more susceptible to loss of connectivity or breakage during movement of the cables causing interruption of the pacing system. The analysis of the returned devices attributed the failure to a design change of the cap housing of the pins. In the last six years, a total of four serious injuries were reported to Oscor which were attributed to a connector cap malfunction causing the lead connector to separate during use potentially leading to an interruption of the pacing system.

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Statement by FDA Commissioner Scott Gottlieb, M.D., on preparations for the upcoming flu season and vaccinations - FDA Press Releases

Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA’s role in preparing for flu season

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Statement from FDA Commissioner Scott Gottlieb, M.D., on modernizing standards of identity and the use of dairy names for plant-based substitutes - FDA Press Releases

FDA issues a request for information to solicit feedback on how consumers are using plant-based substitutes for milk, cheese and other dairy foods.

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Wednesday, September 26, 2018

Isolation of 4,4′-bond secalonic acid D from the marine-derived fungus Penicillium oxalicum with inhibitory property against hepatocellular carcinoma - Journal of Antibiotics

Isolation of 4,4′-bond secalonic acid D from the marine-derived fungus Penicillium oxalicum with inhibitory property against hepatocellular carcinoma

Isolation of 4,4′-bond secalonic acid D from the marine-derived fungus <i>Penicillium oxalicum</i> with inhibitory property against hepatocellular carcinoma, Published online: 27 September 2018; doi:10.1038/s41429-018-0104-5

Isolation of 4,4′-bond secalonic acid D from the marine-derived fungus Penicillium oxalicum with inhibitory property against hepatocellular carcinoma

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Mauna Loa Macadamia Nut Corporation Voluntarily Recalls - FDA Safety Alerts & Drug Recalls

Mauna Loa Macadamia Nut Corporation is voluntarily recalling all of its products produced at the Keaau facility between Sept. 6 - 21, 2018 due to a potential contamination of Escherichia coli (E. coli). The recall was initiated due to E. coli being detected in the well water and distribution system that supplies the firm's operations. No illnesses related to the water have been reported to the state.

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Correction to: Metacytofilin, a novel immunomodulator produced by Metarhizium sp. TA2759 - Journal of Antibiotics

Correction to: Metacytofilin, a novel immunomodulator produced by Metarhizium sp. TA2759

Correction to: Metacytofilin, a novel immunomodulator produced by <i>Metarhizium</i> sp. TA2759, Published online: 27 September 2018; doi:10.1038/s41429-018-0045-z

Correction to: Metacytofilin, a novel immunomodulator produced by Metarhizium sp. TA2759

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Winners of the 2017 JA Ōmura Awards for excellence - Journal of Antibiotics

Winners of the 2017 JA Ōmura Awards for excellence

Winners of the 2017 JA Ōmura Awards for excellence, Published online: 27 September 2018; doi:10.1038/s41429-018-0082-7

Winners of the 2017 JA Ōmura Awards for excellence

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Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA commitment to disclose retailer information for certain food recalls to improve consumer safety - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA commitment to disclose retailer information for certain food recalls to improve consumer safety

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Tuesday, September 25, 2018

Cytotoxic anthracycline and antibacterial tirandamycin analogues from a marine-derived Streptomyces sp. SCSIO 41399 - Journal of Antibiotics

Cytotoxic anthracycline and antibacterial tirandamycin analogues from a marine-derived Streptomyces sp. SCSIO 41399

Cytotoxic anthracycline and antibacterial tirandamycin analogues from a marine-derived <i>Streptomyces</i> sp. SCSIO 41399, Published online: 26 September 2018; doi:10.1038/s41429-018-0103-6

Cytotoxic anthracycline and antibacterial tirandamycin analogues from a marine-derived Streptomyces sp. SCSIO 41399

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Allergy Alert Issued in Whole Foods Market Stores Nationwide for Undeclared Milk in 365 Everyday Value White Corn Tortilla Chips - FDA Safety Alerts & Drug Recalls

Whole Foods Market is voluntarily recalling 365 Everyday Value White Corn Tortilla Chips because the product may contain undeclared milk that was not listed on the product 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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Voluntary Recall on Harris Teeter Low Fat Cookies & Cream Frozen Yogurt Due to Undeclared Peanut Product - FDA Safety Alerts & Drug Recalls

Harris Teeter is notifying shoppers of a voluntarily recall of Harris Teeter Low Fat Frozen Yogurt Cookies & Cream 1.5 qt laminated cartons, UPC 0 72036 98182 0, with all SELL BY DATES up to 07/30/19 due to undeclared peanut product.

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Remarks from Anna Abram as prepared for delivery to the 2018 Intergovermental Meeting on Drug Compounding - FDA Press Releases

Remarks by FDA’s Anna Abram to the 2018 Intergovermental Meeting on Drug Compounding

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Monday, September 24, 2018

FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases - FDA Press Releases

FDA has awarded 12 new clinical trial research grants to enhance the development of medical products for patients with rare diseases

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Friday, September 21, 2018

Purus Labs Issues Allergy Alert on Undeclared Milk and Soy in MyoWhey - FDA Safety Alerts & Drug Recalls

Purus Labs, Inc of Plano, Texas is recalling MyoWhey Chocolate Cookie Crunch, because it may contain undeclared milk and soy. This only effects products with Lot number PL: 0100518 Exp: 04/2020. People who have an allergy or severe sensitivity to milk and soy run the risk of serious or life-threatening allergic reaction if they consume these products.

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Thursday, September 20, 2018

Potential targets for the development of new antifungal drugs - Journal of Antibiotics

Potential targets for the development of new antifungal drugs

Potential targets for the development of new antifungal drugs, Published online: 21 September 2018; doi:10.1038/s41429-018-0100-9

Potential targets for the development of new antifungal drugs

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Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP) For Interruption and/or Inability to Start Therapy at Altitudes above 3,200 Feet/975 Meters - FDA Safety Alerts & Drug Recalls

Getinge is voluntarily initiating a Worldwide recall involving a field correction of approximately 5,223 Maquet/Getinge Cardiosave Intra-Aortic Balloon Pumps (IABP) sold by Datascope Corp., for a potential interruption and/or inability to start therapy to the patient regarding the use of certain Intra-Aortic Balloons (IABs) prior to or during the use with Cardiosave IABP for users who are at altitudes above 3200 feet/975 meters. This condition could potentially lead to patient hemodynamic instability.

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Wednesday, September 19, 2018

Pestiocandin, a new papulacandin class antibiotic isolated from Pestalotiopsis humus - Journal of Antibiotics

Pestiocandin, a new papulacandin class antibiotic isolated from Pestalotiopsis humus

Pestiocandin, a new papulacandin class antibiotic isolated from <i>Pestalotiopsis humus</i>, Published online: 19 September 2018; doi:10.1038/s41429-018-0102-7

Pestiocandin, a new papulacandin class antibiotic isolated from Pestalotiopsis humus

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Tuesday, September 18, 2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s ongoing efforts to prevent foodborne outbreaks of Cyclospora - FDA Press Releases

he safety of the American food supply is one of the U.S. Food and Drug Administration’s highest priorities. A key part of our work in this space focuses on implementing the principles and measures of the FDA Food Safety Modernization Act (FSMA). The actions directed by FSMA are designed to prevent foodborne illness and food safety problems from happening.

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FDA takes important steps to encourage appropriate and rational prescribing of opioids through final approval of new safety measures governing the use of immediate-release opioid analgesic medications - FDA Press Releases

FDA takes important steps to encourage appropriate and rational prescribing of opioids through final approval of new safety measures governing the use of immediate-release opioid analgesic medications.

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Lidl Voluntarily Recalls Bellona Brand Hazelnut Wafers Due to Improperly Declared Wheat Allergen - FDA Safety Alerts & Drug Recalls

Lidl US has voluntarily recalled all Bellona brand “Milk Chocolate Flavored Coated Wafer with Hazelnut Crème Filling and White Chocolate Flavor” confections as a precautionary measure because the allergen statement does not include wheat.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on launch of ‘The Real Cost’ Youth E-Cigarette Prevention Campaign amid evidence of sharply rising use among kids - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., on launch of ‘The Real Cost’ Youth E-Cigarette Prevention Campaign amid evidence of sharply rising use among kids.

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FDA launches new, comprehensive campaign to warn kids about the dangers of e-cigarette use as part of agency’s Youth Tobacco Prevention Plan, amid evidence of - FDA Press Releases

FDA launched new, comprehensive campaign to warn kids about the dangers of e-cigarette use as part of agency’s Youth Tobacco Prevention Plan, amid evidence of sharply rising use among kids.

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Friday, September 14, 2018

FDA approves device for treatment of acute coronary artery perforations - FDA Press Releases

FDA approves device for treatment of acute coronary artery perforations

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Statement from Binita Ashar, M.D., of the FDA’s Center for Devices and Radiological Health on agency’s commitment to studying breast implant safety - FDA Press Releases

FDA Statement on agency’s commitment to studying breast implant safety Short Title: FDA Statement on agency’s commitment to studying breast implant safety

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New phenoxazinone-related alkaloids from strain Streptomyces sp. KIB-H1318 - Journal of Antibiotics

New phenoxazinone-related alkaloids from strain Streptomyces sp. KIB-H1318

New phenoxazinone-related alkaloids from strain <i>Streptomyces</i> sp. KIB-H1318, Published online: 14 September 2018; doi:10.1038/s41429-018-0099-y

New phenoxazinone-related alkaloids from strain Streptomyces sp. KIB-H1318

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Thursday, September 13, 2018

BioLyte Laboratories Issues Voluntary Nationwide Recall Due to the Voluntary Nationwide Recall initiated by King Bio Inc. (a Raw Material Supplier) for NeoRelief for Muscle Cramping and Restlessness Topical Gel Due to Possible Microbial Contamination - FDA Safety Alerts & Drug Recalls

BioLyte Laboratories is voluntarily recalling lot numbers 1138, 1139, 1146, and 1160 of NeoRelief for Muscle Cramping and Restlessness Topical Gel to the retail and consumer level. King Bio Inc., a manufacturer of some of the active ingredients in this product, has been found to have some water contamination issues that potentially could have affected this product. King Bio has issued a recall of these active ingredients in BioLyte’s lot specific product. To date, there have been no reports of illness or injury due to the use of this product.

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FDA provides update on its ongoing investigation into valsartan products; and reports on the finding of an additional impurity identified in one firm’s already recalled products - FDA Press Releases

FDA update on the ongoing investigation into valsartan impurities, recalls and current findings.

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FDA approves new kind of treatment for hairy cell leukemia - FDA Press Releases

FDA approves Lumoxiti (moxetumomab pasudotox-tdfk) for the treatment of adult patients with relapsed or refractory hairy cell leukemia

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Wednesday, September 12, 2018

Bravo Packing, Inc. Recalls Performance Dog Raw Pet Food Because of Possible Salmonella Health Risk to Humans and Animals - FDA Safety Alerts & Drug Recalls

Bravo Packing, Inc. of Carneys Point, NJ is recalling all Performance Dog products, a frozen raw pet food, because it has the potential to be contaminated with Salmonella. Salmonella can cause illness in animals eating the products, as well as people who handle contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products, infected animals or any surfaces exposed to these products.

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Sarap Asian Fusion Recalls Cookies due to Undeclared Allergens - FDA Safety Alerts & Drug Recalls

Sarap Asian Fusion of Garden Grove, CA is recalling Asian Fusion Cookies due to undeclared allergens of wheat, milk and soy. People who have an allergy or severe sensitivity to wheat or 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., and Center for Devices and Radiological Health Director Jeff Shuren, M.D., J.D., on agency efforts to work with tech industry to spur innovation in digital health - FDA Press Releases

FDA Statement on agency efforts to work with tech industry to spur innovation in digital health

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Voluntary Recall Notice of Meijer Taco Seasoning Mix 4.5 oz. - FDA Safety Alerts & Drug Recalls

McCormick & Company, Inc. is initiating a voluntary recall of Meijer Taco Seasoning Mix 4.5 OZ bottle due to an unlabeled milk allergen

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FDA awards five grants to advance the development of pediatric medical devices - FDA Press Releases

FDA has awarded grants to five Pediatric Device Consortia that will provide advice to innovators of children's medical devices

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Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to address epidemic of youth e-cigarette use - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to address epidemic of youth e-cigarette use

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FDA takes new steps to address epidemic of youth e-cigarette use, including a historic action against more than 1,300 retailers and 5 major manufacturers for their roles perpetuating youth access - FDA Press Releases

FDA takes new steps to address epidemic of youth e-cigarette use, including a historic action against more than 1,300 retailers and 5 major manufacturers for their roles perpetuating youth access

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Tuesday, September 11, 2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new warning letters FDA is issuing to companies marketing kratom with unproven medical claims; and the agency’s ongoing concerns about kratom - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., on new warning letters FDA is issuing to companies marketing kratom with unproven medical claims; and the agency’s ongoing concerns about kratom

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Monday, September 10, 2018

Market of Choice Issues Allergy Alert for Undeclared Egg in Sesame Noodle Salad Vegan - FDA Safety Alerts & Drug Recalls

Market of Choice, based in Eugene, Ore., is recalling its Gourmet Take Away Sesame Noodle Salad Vegan, because it contains undeclared egg. People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening allergic reactions if they consume this product.

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Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of all Sterile Compounded Drugs Due to A Potential Lack of Sterility Assurance - FDA Safety Alerts & Drug Recalls

Pharm D Solutions, LLC is voluntarily recalling all sterile compounded drug products within expiry to the clinic, physician or consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA.

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USDA and FDA announce joint public meeting on use of animal cell culture technology to develop products derived from livestock and poultry - FDA Press Releases

WASHINGTON, Sept. 10, 2018 – U.S. Secretary of Agriculture Sonny Perdue, DVM and U.S. Food and Drug Administration Commissioner Scott Gottlieb, M.D. today announced a joint public meeting to be held on Oct. 23-24, 2018 to discuss the use of cell culture technology to develop products derived from livestock and poultry.

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Saturday, September 8, 2018

Steve’s Real Food Voluntarily Recalls One Lot of Turducken Recipe, One Lot of Quest Emu, and One Lot of Quest Beef Due to Possible Salmonella and L. Mono Contamination - FDA Safety Alerts & Drug Recalls

Steve’s Real Food of Salt Lake City, Utah is voluntarily recalling one lot of 5lb Turducken Recipe, one lot of 2lb Quest Emu Diet, and one lot of 2lb Quest Beef Diet, due to their possible Salmonella and/or L. mono contamination.

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Gravel Ridge Farms Recalls Cage Free Egg Due to Possible Salmonella Contamination - FDA Safety Alerts & Drug Recalls

Gravel Ridge Farms is recalling Cage Free Large Eggs due to a potential contamination of Salmonella. The recall was initiated because reported illnesses were confirmed at locations using Gravel Ridge Farm Eggs, and we are voluntarily recalling out of an abundance of caution.

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Friday, September 7, 2018

FDA approves new dosage strength of buprenorphine and naloxone sublingual film as maintenance treatment for opioid dependence - FDA Press Releases

FDA approved Cassipa (buprenorphine and naloxone) sublingual film (applied under the tongue) for the maintenance treatment of opioid dependence.

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Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up - FDA Safety Alerts & Drug Recalls

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

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Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to help ensure the quality of and preserve access to compounded drugs by pursuing closer collaboration with states - FDA Press Releases

FDA announces revised draft memorandum of understanding between FDA and the states to help ensure the quality of and preserve access to compounded drugs

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SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate - FDA Safety Alerts & Drug Recalls

, SCA Pharmaceuticals LLC (“SCA Pharma”) is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate.

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Thursday, September 6, 2018

Beaumont Bio Med, Inc. Issues Voluntary Nationwide Recall of all their Homeopathic Aqueous/Alcohol-Based Medicines due to the Nationwide Recall by the Contract Manufacturer, King Bio, of all their Aqueous-Based Products due to Possible Microbial Contamination - FDA Safety Alerts & Drug Recalls

Beaumont Bio Med, Inc. is voluntarily recalling its entire aqueous/alcohol-based product line for human use, within expiry, to the consumer level. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on an updated approach for including added sugar information on the Nutrition Facts labels of pure maple syrup and honey - FDA Press Releases

Proposed rule revises front of package calorie labeling requirements to provide more flexibility to industry

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Wednesday, September 5, 2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s global efforts to help assure product quality and transparency at foreign drug manufacturing facilities - FDA Press Releases

FDA is publishing its internal policy for how manufacturing facilities are prioritized and scheduled for surveillance inspections in an effort to ensure the quality and safety of globally produced products.

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Tuesday, September 4, 2018

Dormant Mycobacterium tuberculosis converts isoniazid to the active drug in a Wayne’s model of dormancy - Journal of Antibiotics

Dormant Mycobacterium tuberculosis converts isoniazid to the active drug in a Wayne’s model of dormancy

Dormant <i>Mycobacterium tuberculosis</i> converts isoniazid to the active drug in a Wayne’s model of dormancy, Published online: 05 September 2018; doi:10.1038/s41429-018-0098-z

Dormant Mycobacterium tuberculosis converts isoniazid to the active drug in a Wayne’s model of dormancy

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H&C Food Inc. Issues Allergy Alert on Undeclared Wheat, Pork, Egg, and Crustacean in Frozen Fish Balls - FDA Safety Alerts & Drug Recalls

H&C Food Inc of Brooklyn, NY is recalling the Frozen Fuzhou Fish Balls and the Fish Balls, because they may contain undeclared wheat, pork, egg, and crustacean. People who have an allergy or severe sensitivity to wheat, pork, egg and crustacean run the risk of serious or life-threatening allergic reaction if they consume these products.

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Monday, September 3, 2018

A new antitrypanosomal alkaloid from the Red Sea marine sponge Hyrtios sp. - Journal of Antibiotics

A new antitrypanosomal alkaloid from the Red Sea marine sponge Hyrtios sp.

A new antitrypanosomal alkaloid from the Red Sea marine sponge <i>Hyrtios</i> sp., Published online: 04 September 2018; doi:10.1038/s41429-018-0092-5

A new antitrypanosomal alkaloid from the Red Sea marine sponge Hyrtios sp.

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Celludinones, new inhibitors of sterol O-acyltransferase, produced by Talaromyces cellulolyticus BF-0307 - Journal of Antibiotics

Celludinones, new inhibitors of sterol O-acyltransferase, produced by Talaromyces cellulolyticus BF-0307

Celludinones, new inhibitors of sterol <i>O</i>-acyltransferase, produced by <i>Talaromyces cellulolyticus</i> BF-0307, Published online: 03 September 2018; doi:10.1038/s41429-018-0097-0

Celludinones, new inhibitors of sterol O-acyltransferase, produced by Talaromyces cellulolyticus BF-0307

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