Thursday, February 28, 2019

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical Ingredient (API) - FDA Safety Alerts & Drug Recalls

Camber Pharmaceuticals, Inc. is recalling 87 lots of Losartan Tablets USP 25 mg, 50 mg, and 100 mg to consumer level. This recall was prompted due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

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FDA warns CanaRx for selling unapproved, misbranded and unsafe imported drugs to unsuspecting Americans - FDA Press Releases

FDA issued a warning letter to CanaRx for illegally distributing drugs into the U.S. that have not been approved by the FDA for safety and effectiveness.

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Albumycin, a new isoindolequinone from Streptomyces albus J1074 harboring the fluostatin biosynthetic gene cluster - Journal of Antibiotics

Albumycin, a new isoindolequinone from Streptomyces albus J1074 harboring the fluostatin biosynthetic gene cluster

Albumycin, a new isoindolequinone from <i>Streptomyces albus</i> J1074 harboring the fluostatin biosynthetic gene cluster, Published online: 28 February 2019; doi:10.1038/s41429-019-0161-4

Albumycin, a new isoindolequinone from Streptomyces albus J1074 harboring the fluostatin biosynthetic gene cluster

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Glycosylation of an allenic erythronolide - Journal of Antibiotics

Glycosylation of an allenic erythronolide

Glycosylation of an allenic erythronolide, Published online: 28 February 2019; doi:10.1038/s41429-019-0156-1

Glycosylation of an allenic erythronolide

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Wednesday, February 27, 2019

Joy Gourmet Foods LLC Issues Allergy Alert on Undeclared Sulfites - FDA Safety Alerts & Drug Recalls

Joy Gourmet Foods Inc. of Maspeth, NY is recalling its Joy Brand Chutneys and Pastes products because they contain undeclared sulfites.. People who have allergies to sulfites run the risk of serious or life-threatening allergic reaction if they consume this product. The recalled Joy Brand Chutneys and Pastes were distributed in NY, NJ,and CT in retail stores.The products comes in 8 oz,14 oz,16 oz, and 26 oz, 32 oz. clear glass jar packages and marked on the labels as follows:

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Statement from FDA Commissioner Scott Gottlieb, M.D. as prepared for oral testimony before the U.S. House Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, Committee on Appropriations - FDA Press Releases

FDA addresses the U.S. House Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, Committee on Appropriations

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Tuesday, February 26, 2019

UTZ Quality Foods Issues Allergy Alert on Undeclared Milk in Bachman 10 Ounce Twist - FDA Safety Alerts & Drug Recalls

Utz Quality Foods, LLC., is voluntarily recalling a specific expiration date code of Bachman 10 oz Twist Pretzel packages due to undeclared milk. This recall was initiated after reviewing production records which identified a small number of packages were mislabeled.

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ICU Medical Issues a Voluntary Nationwide Recall of Certain Lots of ChemoLock™ and ChemoClave® Vial Spikes Due to the Potential for Burr Particulate - FDA Safety Alerts & Drug Recalls

ICU Medical, Inc. today announced a voluntary recall of certain lots of ChemoLock™ and ChemoClave® Vial Spikes due to the potential for burr particulate originating from the protective cap used in the assembly of the device

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Statement from FDA Commissioner Scott Gottlieb, M.D. on the agency’s 2019 policy and regulatory agenda for continued action to forcefully address the tragic epidemic of opioid abuse - FDA Press Releases

FDA outlines 2019 policy and regulatory agenda for continued action to forcefully address the tragic epidemic of opioid abuse.

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FDA, CDC, and CMS launch task force to help facilitate rapid availability of diagnostic tests during public health emergencies - FDA Press Releases

FDA, CDC, and CMS launch task force to help facilitate rapid availability of diagnostic tests during public health emergencies

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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 FDA’s modern approach to advanced pharmaceutical manufacturing - FDA Press Releases

FDA issues information to industry on advanced pharmaceutical manufacturing

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Monday, February 25, 2019

Southern Specialties Voluntarily Recalls Bagged Green Beans and Butternut Squash Distributed in Southeast because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Southern Specialties Inc. of Pompano Beach, Florida is voluntarily recalling select bags of Marketside brand green beans and butternut squash because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

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Statement from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas on a new strategy to advance FDA’s food safety mission and modernize oversight of imported food - FDA Press Releases

American consumers expect a diverse, robust and fresh food supply that’s affordable and safe all year round. Since not all food products can be produced solely by domestic facilities, to help meet these demands, the U.S. imports about 15 percent of its overall food supply from more than 200 countries or territories representing about 125,000 international food facilities and farms. Over the past 15 years alone, we’ve seen a trend of rising imported foods. Other countries now supply about 32 percent of the fresh vegetables, 55 percent of the fresh fruit and 94 percent of the seafood that Americans enjoy.

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Golean Detox USA Issues Voluntary Nationwide Recall of Golean DETOX Capsules Due to Presence of Undeclared Sibutramine and Phenolphthalein - FDA Safety Alerts & Drug Recalls

Golean Detox USA, Charlotte, NC is voluntarily recalling all lots within expiry of Golean DETOX capsules to the consumer level. FDA analysis has found Golean DETOX capsules to be tainted with undeclared sibutramine and phenolphthalein. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market due to safety concerns. Phenolphthalein was once an ingredient used in over-the-counter laxatives, but because of concerns of carcinogenicity is not currently approved for marketing in the United States. The presence of sibutramine and phenolphthalein in Golean DETOX renders it an unapproved drug for which safety and efficacy has not been established and, therefore, subject to recall.

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B&G Foods Voluntarily Recalls a Limited Number of Jars of Victoria® Marinara Sauce Due to Possible Undeclared Cashew - FDA Safety Alerts & Drug Recalls

B&G Foods announced today it is voluntarily recalling 1,280 cases of a single date code of 40 oz. Victoria Marinara Sauce, with a “best by” date of 03/06/2022, after learning that the product may contain cashew allergens that are not declared on the product’s ingredient statement. People who have an allergy or severe sensitivity to cashew run the risk of serious or life-threatening allergic reaction if they consume this product. There is no health risk associated with this product for individuals without an allergy to tree nuts.

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Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity - FDA Safety Alerts & Drug Recalls

Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg to the consumer level due to the detection of trace amounts of an unexpected impurity (NDEA) found in finished product manufactured with active pharmaceutical ingredient made by Hetero Labs Limited.

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FDA issues warning letter to clinic illegally marketing unapproved thermography device, warns consumers to avoid using thermography devices to detect breast cancer - FDA Press Releases

FDA issues warning letter to clinic illegally marketing unapproved thermography device, warns consumers to avoid using thermography devices to detect breast cancer

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Construction of a 6/5/9-membered tricyclic structure of cladiellins via radical-polar crossover reaction - Journal of Antibiotics

Construction of a 6/5/9-membered tricyclic structure of cladiellins via radical-polar crossover reaction

Construction of a 6/5/9-membered tricyclic structure of cladiellins via radical-polar crossover reaction, Published online: 25 February 2019; doi:10.1038/s41429-019-0150-7

Construction of a 6/5/9-membered tricyclic structure of cladiellins via radical-polar crossover reaction

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Sunday, February 24, 2019

Modification of drug-binding proteins associated with the efflux pump in MDR-MTB in course of evolution: an unraveled clue based on in silico approach - Journal of Antibiotics

Modification of drug-binding proteins associated with the efflux pump in MDR-MTB in course of evolution: an unraveled clue based on in silico approach

Modification of drug-binding proteins associated with the efflux pump in MDR-MTB in course of evolution: an unraveled clue based on in silico approach, Published online: 25 February 2019; doi:10.1038/s41429-019-0146-3

Modification of drug-binding proteins associated with the efflux pump in MDR-MTB in course of evolution: an unraveled clue based on in silico approach

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Friday, February 22, 2019

Meijer Recalls Mint Meijer Brand Ultimate Chocolate Mint Chip Cookies Due to an Undeclared Soy Allergen - FDA Safety Alerts & Drug Recalls

Meijer is announcing a voluntary recall of its Meijer brand Ultimate Chocolate Mint Chip Cookies because soy it is not properly declared on the label.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to spur development of innovative devices, including new advancements in novel brain implants, that can help patients with paralysis or amputation gain mobility - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to spur development of innovative devices, including new advancements in novel brain implants, that can help patients with paralysis or amputation gain mobility

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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 the FDA’s continuing efforts to maintain its strong oversight of generic drug quality issues domestically and abroad - FDA Press Releases

FDA outlines continuing efforts to maintain its strong oversight of generic drug quality issues domestically and abroad

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4-O-Methylascochlorin inhibits the prolyl hydroxylation of hypoxia-inducible factor-1α, which is attenuated by ascorbate - Journal of Antibiotics

4-O-Methylascochlorin inhibits the prolyl hydroxylation of hypoxia-inducible factor-1α, which is attenuated by ascorbate

4-<i>O</i>-Methylascochlorin inhibits the prolyl hydroxylation of hypoxia-inducible factor-1α, which is attenuated by ascorbate, Published online: 22 February 2019; doi:10.1038/s41429-019-0157-0

4-O-Methylascochlorin inhibits the prolyl hydroxylation of hypoxia-inducible factor-1α, which is attenuated by ascorbate

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1-Amino-2′-fucosyllactose inhibits biofilm formation by Streptococcus agalactiae - Journal of Antibiotics

1-Amino-2′-fucosyllactose inhibits biofilm formation by Streptococcus agalactiae

1-Amino-2′-fucosyllactose inhibits biofilm formation by <i>Streptococcus agalactiae</i>, Published online: 22 February 2019; doi:10.1038/s41429-019-0151-6

1-Amino-2′-fucosyllactose inhibits biofilm formation by Streptococcus agalactiae

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Thursday, February 21, 2019

Statement from FDA Commissioner Scott Gottlieb, M.D., on additional steps by the agency to support the development of safe and effective novel nicotine replacement therapies to help smokers quit cigarettes - FDA Press Releases

FDA releases the second of two draft guidances aimed at supporting the development of novel nicotine replacement therapies.

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FDA advances new proposed regulation to make sure that sunscreens are safe and effective - FDA Press Releases

FDA issues a proposed rule that would update regulatory requirements for most sunscreen products in the United States

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Novel 5-substituted derivatives of 2’-deoxy-6-azauridine with antibacterial activity - Journal of Antibiotics

Novel 5-substituted derivatives of 2’-deoxy-6-azauridine with antibacterial activity

Novel 5-substituted derivatives of 2’-deoxy-6-azauridine with antibacterial activity, Published online: 21 February 2019; doi:10.1038/s41429-019-0158-z

Novel 5-substituted derivatives of 2’-deoxy-6-azauridine with antibacterial activity

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Nonomuraea suaedae sp. nov., isolated from rhizosphere soil of Suaeda maritima (L.) Dumort - Journal of Antibiotics

Nonomuraea suaedae sp. nov., isolated from rhizosphere soil of Suaeda maritima (L.) Dumort

<i>Nonomuraea suaedae</i> sp. nov., isolated from rhizosphere soil of <i>Suaeda maritima</i> (L.) Dumort, Published online: 21 February 2019; doi:10.1038/s41429-019-0159-y

Nonomuraea suaedae sp. nov., isolated from rhizosphere soil of Suaeda maritima (L.) Dumort

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High-throughput identification of the sensitivities of an Escherichia coli ΔrecA mutant strain to various chemical compounds - Journal of Antibiotics

High-throughput identification of the sensitivities of an Escherichia coli ΔrecA mutant strain to various chemical compounds

High-throughput identification of the sensitivities of an <i>Escherichia coli</i> Δ<i>recA</i> mutant strain to various chemical compounds, Published online: 21 February 2019; doi:10.1038/s41429-019-0160-5

High-throughput identification of the sensitivities of an Escherichia coli ΔrecA mutant strain to various chemical compounds

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Secondary metabolites produced by the citrus phytopathogen Phyllosticta citricarpa - Journal of Antibiotics

Secondary metabolites produced by the citrus phytopathogen Phyllosticta citricarpa

Secondary metabolites produced by the citrus phytopathogen <i>Phyllosticta citricarpa</i>, Published online: 21 February 2019; doi:10.1038/s41429-019-0154-3

Secondary metabolites produced by the citrus phytopathogen Phyllosticta citricarpa

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A transannular approach toward lycopodine synthesis - Journal of Antibiotics

A transannular approach toward lycopodine synthesis

A transannular approach toward lycopodine synthesis, Published online: 21 February 2019; doi:10.1038/s41429-019-0155-2

A transannular approach toward lycopodine synthesis

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Wednesday, February 20, 2019

Antimicrobial potential of myristic acid against Listeria monocytogenes in milk - Journal of Antibiotics

Antimicrobial potential of myristic acid against Listeria monocytogenes in milk

Antimicrobial potential of myristic acid against <i>Listeria monocytogenes</i> in milk, Published online: 21 February 2019; doi:10.1038/s41429-019-0152-5

Antimicrobial potential of myristic acid against Listeria monocytogenes in milk

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Jacques Torres Manufacturing LLC Issues Allergy Alert on Undeclared Milk Allergens in “Jacques” Big Daddy Dark Chocolate Bar - FDA Safety Alerts & Drug Recalls

Jacques Torres Manufacturing LLC of Brooklyn, New York is recalling its 2.2 lbs. (1kg), “Jacques” Big Daddy Dark Chocolate Bar, because it contains undeclared milk allergens. Consumers who are allergic to milk allergens may run the risk of serious or life-threatening allergic reaction if they consume this product.

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Gilda Industries, Inc. Issues Allergy Alert on Undeclared Milk in Butter Pound Cake - FDA Safety Alerts & Drug Recalls

Gilda Industries, Inc voluntarily recalls select code dates and manufacturing lot numbers of Panque – Butter pound cake because they may contain undeclared milk . People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume the product contained inside the recalled panque –butter pound cake

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Tuesday, February 19, 2019

Concord Fresh Success Recall Mild Salsa Seasoning Mix Due To Undeclared Milk Allergen - FDA Safety Alerts & Drug Recalls

Concord Foods, LLC of Brockton, Massachusetts is recalling Concord Fresh Success Mild Salsa Seasoning Mix because it may contain undeclared milk allergen. People who have an allergy or severe sensitivity to milk allergen run the risk of serious or lifethreatening allergic reaction if they consume this product.

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Statement from FDA Commissioner Scott Gottlieb, M.D., and Director of FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D., Ph.D., cautioning consumers against receiving young donor plasma infusions that are promoted as unproven treatment for varying conditions - FDA Press Releases

FDA statement cautioning consumers against receiving young donor plasma infusions that are promoted as unproven treatment for varying conditions

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Monday, February 18, 2019

Chukar Cherries Expands Recall Of Amaretto Rainier Ultra Dark Chocolate Cherries Pouches Due To Undeclared Milk - FDA Safety Alerts & Drug Recalls

February 18, 2019, Chukar Cherries of Prosser, WA is recalling 7.5oz Amaretto Rainier Ultra Dark 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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Saturday, February 16, 2019

Smoked Alaska Seafoods, Inc. Recalls 6.5 oz Jars & Cans of Smoked Silver Salmon Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Smoked Alaska Seafoods, Inc. of Wasilla, AK is recalling all jars and cans of Smoked Silver Salmon in 6.5 oz. containers with the production code of AL81111133 on the bottom of the jar/can because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.

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Friday, February 15, 2019

Nature’s Path Foods Recalls A Specific Production Run Of Envirokidz Choco Chimps, Gorilla Munch And Jungle Munch Cereals Due To Undeclared Gluten - FDA Safety Alerts & Drug Recalls

Today, Nature’s Path Foods announced a voluntary recall of a specific production run of EnviroKidz Choco Chimps, Gorilla Munch and Jungle Munch cereals for they may contain undeclared gluten (wheat and barley). People who have a wheat allergy, celiac disease or sensitivity to gluten and wheat should not consume the cereals with the BEST BEFORE DATE listed below due to potential adverse health effects. Nature’s Path is also removing any affected cereals from customer store shelves and warehouses.

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Kingston Pharma, LLC Issues Voluntary Recall of All Lots of “DG™ Baby Gripe Water Due to Undissolved Ingredient, Citrus Flavonoid - FDA Safety Alerts & Drug Recalls

Kingston Pharma, LLC is voluntarily recalling all lots of “DG™ Baby Gripe Water herbal supplement with organic ginger and fennel extracts” to the consumer level due to the presence of an undissolved ingredient, citrus flavonoid.

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Sid Wainer and Son Initiates Class 2 Recall for Jansal Valley Dukkah Due to Potential Glass Pieces - FDA Safety Alerts & Drug Recalls

Sid Wainer and Son of New Bedford, MA is voluntarily recalling Jansal Valley brand Dukkah in 2.5oz containers because of the potential of it containing glass pieces

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Statement from FDA Commissioner Scott Gottlieb, M.D., on new policy to improve access and foster price competition for drugs that face inadequate generic competition - FDA Press Releases

FDA announces new draft guidance titled, Competitive Generic Therapies, to help provide even greater clarity to industry about the CGT pathway.

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Thursday, February 14, 2019

FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices - FDA Press Releases

FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices

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FDA issues warning letter to doctor for illegally marketing unapproved device with claims to prevent and treat tightening of scar tissue around breast implants - FDA Press Releases

FDA issues warning letter to doctor for illegally marketing unapproved device with claims to prevent and treat tightening of scar tissue around breast implants

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Wednesday, February 13, 2019

Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Frank Yiannas on findings from the agency’s investigation of the November 2018 outbreak of E. coli O157:H7 in California-linked romaine lettuce - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Frank Yiannas on findings from the agency’s investigation of the November 2018 outbreak of E. coli O157:H7 in California-linked romaine lettuce

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Statement from FDA Commissioner Scott Gottlieb, M.D. on new programs to promote the adoption of innovations in drug manufacturing that can improve quality and lower drug costs - FDA Press Releases

FDA announces programs to promote adoption of innovations in drug manufacturing

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Ottogi America, Inc. Expands Recall on Undeclared Egg in Products - FDA Safety Alerts & Drug Recalls

Ottogi America, Inc. announced today it is expanding its recall to include the two items below due to a possibility of containing egg ingredient undeclared on the packages. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction of they consume these products.

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Synthesis of the ABCDG ring skeleton of communesin F based on carboborylation of 1,3-diene and Bi(OTf)3-catalyzed cyclizations - Journal of Antibiotics

Synthesis of the ABCDG ring skeleton of communesin F based on carboborylation of 1,3-diene and Bi(OTf)3-catalyzed cyclizations

Synthesis of the ABCDG ring skeleton of communesin F based on carboborylation of 1,3-diene and Bi(OTf)<sub>3</sub>-catalyzed cyclizations, Published online: 13 February 2019; doi:10.1038/s41429-019-0142-7

Synthesis of the ABCDG ring skeleton of communesin F based on carboborylation of 1,3-diene and Bi(OTf)3-catalyzed cyclizations

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Total Synthesis of trans-Resorcylide via Macrocyclic Stille Carbonylation - Journal of Antibiotics

Total Synthesis of trans-Resorcylide via Macrocyclic Stille Carbonylation

Total Synthesis of <i>trans</i>-Resorcylide via Macrocyclic Stille Carbonylation, Published online: 13 February 2019; doi:10.1038/s41429-019-0145-4

Total Synthesis of trans-Resorcylide via Macrocyclic Stille Carbonylation

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Synthesis and antibiotic activity of novel acylated phloroglucinol compounds against methicillin-resistant Staphylococcus aureus - Journal of Antibiotics

Synthesis and antibiotic activity of novel acylated phloroglucinol compounds against methicillin-resistant Staphylococcus aureus

Synthesis and antibiotic activity of novel acylated phloroglucinol compounds against methicillin-resistant <i>Staphylococcus aureus</i>, Published online: 13 February 2019; doi:10.1038/s41429-019-0153-4

Synthesis and antibiotic activity of novel acylated phloroglucinol compounds against methicillin-resistant Staphylococcus aureus

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Tuesday, February 12, 2019

Statement from FDA Commissioner Scott Gottlieb, M.D., on ongoing efforts to stop the spread of illicit opioids, further secure the U.S. drug supply chain and forcefully confront opioid epidemic - FDA Press Releases

FDA issues first warning letter under Drug Supply Chain Security Act to McKesson Corp. for violations highlighted by a concerning tampering incident.

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Monday, February 11, 2019

Lactacystin: first-in-class proteasome inhibitor still excelling and an exemplar for future antibiotic research - Journal of Antibiotics

Lactacystin: first-in-class proteasome inhibitor still excelling and an exemplar for future antibiotic research

Lactacystin: first-in-class proteasome inhibitor still excelling and an exemplar for future antibiotic research, Published online: 12 February 2019; doi:10.1038/s41429-019-0141-8

Lactacystin: first-in-class proteasome inhibitor still excelling and an exemplar for future antibiotic research

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Design and fabrication of novel thiourea coordination compounds as potent inhibitors of bacterial growth - Journal of Antibiotics

Design and fabrication of novel thiourea coordination compounds as potent inhibitors of bacterial growth

Design and fabrication of novel thiourea coordination compounds as potent inhibitors of bacterial growth, Published online: 12 February 2019; doi:10.1038/s41429-019-0147-2

Design and fabrication of novel thiourea coordination compounds as potent inhibitors of bacterial growth

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In vitro activities of antimicrobial peptides and ceragenins against Legionella pneumophila - Journal of Antibiotics

In vitro activities of antimicrobial peptides and ceragenins against Legionella pneumophila

In vitro activities of antimicrobial peptides and ceragenins against <i>Legionella pneumophila</i>, Published online: 12 February 2019; doi:10.1038/s41429-019-0148-1

In vitro activities of antimicrobial peptides and ceragenins against Legionella pneumophila

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Statement from FDA Commissioner Scott Gottlieb, M.D., on new data demonstrating rising youth use of tobacco products and the agency’s ongoing actions to confront the epidemic of youth e-cigarette use - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., on new data demonstrating rising youth use of tobacco products and the agency’s ongoing actions to confront the epidemic of youth e-cigarette use.

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World Waters Issues Voluntary Recall of Select WTRMLN WTR Original 12 Packs Due To The Possible Presence of Soft Plastic Pieces. Company Urges Consumers to Check Packages Prior to Consumption - FDA Safety Alerts & Drug Recalls

World Waters, LLC is initiating a voluntary recall of certain lots of Cold Pressed Juice Watermelon WTRMLN WTR Original 12 packs due to the potential presence of soft plastic that may be loosely floating in some of the finished products

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Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight - FDA Press Releases

FDA announces new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight

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FDA takes action against 17 companies for illegally selling products claiming to treat Alzheimer’s disease - FDA Press Releases

FDA takes action against 17 companies for illegally selling products claiming to treat Alzheimer’s disease

from Food and Drug Administration--Press Releases http://bit.ly/2UTEOg4
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Friday, February 8, 2019

Birdseed Food Co. Issues Allergy Alert on Undeclared Cashews in Craft Granola Goldenola Turmeric & Ginger - FDA Safety Alerts & Drug Recalls

BIRDSEED FOOD CO. of Bend, OR is recalling Craft Granola Goldenola Turmeric & Ginger that was sold between the dates of 10/03/18 - 02/07/19, because it contains undeclared cashews. People who have an allergy or severe sensitivity to cashews run the risk of serious or life-threatening allergic reaction if they consume this product.

from Food and Drug Administration--Recalls/Safety Alerts http://bit.ly/2ROu80n
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McDaniel Life-Line LLC Issues Voluntary Worldwide Recall of Indian Herb - FDA Safety Alerts & Drug Recalls

Felt, OK, McDaniel Life-Line LLC is voluntarily recalling all lots of Indian Herb to the consumer level. This product is being recalled because it is marketed without an approved NDA/ANDA. The therapeutic claims made in the labeling for this product establish that it is a drug because it is an article (other than food) intended to affect the structure or any function of the body. Additionally, the product contains ingredients that the Agency has determined to be caustic in nature that can cause serious injury.

from Food and Drug Administration--Recalls/Safety Alerts http://bit.ly/2MXYMDI
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Doxycycline inhibits pre-rRNA processing and mature rRNA formation in E. coli - Journal of Antibiotics

Doxycycline inhibits pre-rRNA processing and mature rRNA formation in E. coli

Doxycycline inhibits pre-rRNA processing and mature rRNA formation in <i>E. coli</i>, Published online: 08 February 2019; doi:10.1038/s41429-019-0149-0

Doxycycline inhibits pre-rRNA processing and mature rRNA formation in E. coli

from The Journal of Antibiotics - Issue - nature.com science feeds https://go.nature.com/2MV7Adn
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GKK1032C, a new alkaloid compound from the endophytic fungus Penicillium sp. CPCC 400817 with activity against methicillin-resistant S. aureus - Journal of Antibiotics

GKK1032C, a new alkaloid compound from the endophytic fungus Penicillium sp. CPCC 400817 with activity against methicillin-resistant S. aureus

GKK1032C, a new alkaloid compound from the endophytic fungus <i>Penicillium</i> sp. CPCC 400817 with activity against methicillin-resistant <i>S. aureus</i>, Published online: 08 February 2019; doi:10.1038/s41429-019-0144-5

GKK1032C, a new alkaloid compound from the endophytic fungus Penicillium sp. CPCC 400817 with activity against methicillin-resistant S. aureus

from The Journal of Antibiotics - Issue - nature.com science feeds https://go.nature.com/2BqiXWa
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Thursday, February 7, 2019

FDA takes new steps to adopt more modern technologies for improving the security of the drug supply chain through innovations that improve tracking and tracing of medicines - FDA Press Releases

FDA announces pilot program to improve ability to trace prescription drugs at all points in the drug distribution chain.

from Food and Drug Administration--Press Releases http://bit.ly/2TDepCW
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FDA pursues order barring specific retailers from selling tobacco products as part of its continuing efforts to target youth tobacco use - FDA Press Releases

FDA has initiated enforcement action against certain retail locations of Walgreen Co. and Circle K Stores Inc. for repeated violations of restrictions on the sale and distribution of tobacco products, including sales of cigars and menthol cigarettes to minors.

from Food and Drug Administration--Press Releases http://bit.ly/2DYcTpt
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Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the agency’s process for issuing public warnings and notifications of recalls - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the agency’s process for issuing public warnings and notifications of recalls

from Food and Drug Administration--Press Releases http://bit.ly/2GdOQp5
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Wednesday, February 6, 2019

Statement from Binita Ashar, M.D., of the FDA’s Center for Devices and Radiological Health on agency’s continuing efforts to educate patients on known risk of lymphoma from breast implants - FDA Press Releases

Statement from Binita Ashar, M.D., of the FDA’s Center for Devices and Radiological Health on agency’s continuing efforts to educate patients on known risk of lymphoma from breast implants

from Food and Drug Administration--Press Releases http://bit.ly/2Gtw3VY
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Federal court enters consent decree against Ranier’s Rx Laboratory and owner for manufacturing purportedly sterile drug products in insanitary conditions - FDA Press Releases

Federal court enters consent decree against Ranier’s Rx Laboratory and owner for manufacturing purportedly sterile drug products in insanitary conditions

from Food and Drug Administration--Press Releases http://bit.ly/2DbIjHw
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FDA approves first therapy for the treatment of adult patients with a rare blood clotting disorder - FDA Press Releases

FDA approved Cablivi (caplacizumab-yhdp) injection, the first therapy specifically indicated, in combination with plasma exchange and immunosuppressive therapy, for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), a rare and life-threatening disorder that causes blood clotting.

from Food and Drug Administration--Press Releases http://bit.ly/2t6edAt
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Monday, February 4, 2019

Frito-Lay Issues Voluntary Allergy Alert on Undeclared Milk In Small Number of Stacy’s Simply Naked Pita Chips - FDA Safety Alerts & Drug Recalls

Frito-Lay announced a limited voluntary recall of a very small number of 7 1/3 oz. bags of Stacy’s Simply Naked Pita Chips because they may contain undeclared milk ingredients. People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume the product contained inside the recalled pita chips bags.

from Food and Drug Administration--Recalls/Safety Alerts http://bit.ly/2Ts2zLW
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Allergy Alert Issued by Santa Rosa Whole Foods Market for Undeclared Walnut, Milk and Eggs in “Hipster Chipster” Cookies - FDA Safety Alerts & Drug Recalls

The Santa Rosa Whole Foods Market store is voluntarily recalling eight packages of its “Hipster Chipster” cookies because they contain undeclared tree nut (walnut), milk, and egg allergens that were not listed on the product label.

from Food and Drug Administration--Recalls/Safety Alerts http://bit.ly/2ScHOHx
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Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL Due to Mislabeling - FDA Safety Alerts & Drug Recalls

Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) announced that it’s wholly owned subsidiary, Dr Reddy’s Laboratories, Inc is continuing its voluntary nationwide recall of lot ABD807 of Levetiracetram in 0.54% Sodium Chloride Injection, 1,500 mg/100 mL (15 mg/mL) single-dose infusion bags to the hospital level in U.S.A.

from Food and Drug Administration--Recalls/Safety Alerts http://bit.ly/2RDK9pv
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Friday, February 1, 2019

Stryker Launches Voluntary Field Action for Specific Units of the LIFEPAK® 15 Monitor/Defibrillator - FDA Safety Alerts & Drug Recalls

The company is notifying certain LIFEPAK 15 customers of an issue that may cause the device to lock up after a defibrillation shock is delivered. The lock-up condition is defined as a blank monitor display with LED lights on, indicating power to the device, but no response in the keypad and device functions. A device in this condition has the potential to delay delivery of therapy, and this delay in therapy has the potential to result in serious injury or death.

from Food and Drug Administration--Recalls/Safety Alerts http://bit.ly/2BgZt6c
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FDA warns patients and doctors about recall of home-use test strips used with device to monitor blood thinner warfarin, not authorized for sale in U.S. - FDA Press Releases

Medical product distributor issued voluntary recall of certain Roche Diagnostics test strips used with CoaguChek test meter devices.

from Food and Drug Administration--Press Releases http://bit.ly/2t3AvTe
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