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    Enforcement Report - Week of May 31, 2023
    Enforcement Report - Week of May 31, 2023

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-may-31-2023-56013.pdf

    FDA
    31 May 2023
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    Fresenius Kabi`s Generic Testosterone Receives Approval In US
    Fresenius Kabi`s Generic Testosterone Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211428

    FDA
    15 Nov 2021
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    Efruxifermin Associated With Improved Glucose Metabolism in Patients
    Efruxifermin Associated With Improved Glucose Metabolism in Patients

    https://www.firstwordpharma.com/node/1842002?tsid=4

    FIRSTWORDPHARMA
    29 Jun 2021
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    ADA: Senseonics shows off accuracy for 180-day glucose sensor
    ADA: Senseonics shows off accuracy for 180-day glucose sensor

    https://www.fiercebiotech.com/medtech/ada-senseonics-shows-off-long-term-accuracy-its-six-month-implanted-glucose-sensor

    FIERCEBIOTECH
    28 Jun 2021
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    Rezolute Added to Russell Microcap® Index
    Rezolute Added to Russell Microcap® Index

    https://www.globenewswire.com/news-release/2021/06/28/2253743/0/en/Rezolute-Added-to-Russell-Microcap-Index.html

    GLOBENEWSWIRE
    28 Jun 2021
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    Centre issues guidelines for management of black fungus in kids below 18
    Centre issues guidelines for management of black fungus in kids below 18

    https://economictimes.indiatimes.com/industry/healthcare/biotech/healthcare/centre-issues-guidelines-for-management-of-black-fungus-in-kids-below-18/articleshow/83393945.cms

    ECONOMIC TIMES
    09 Jun 2021
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    Intl Medication Sys`s Generic Dextrose API Receives Approval In US
    Intl Medication Sys`s Generic Dextrose API Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203451

    FDA
    31 Mar 2021
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     Baxter Announces USFDA Approval of Clinimix and Clinimix E
     Baxter Announces USFDA Approval of Clinimix and Clinimix E

    https://www.businesswire.com/news/home/20200923005309/en

    BUSINESSWIRE
    23 Sep 2020
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    Baxter Announces U.S. FDA Approval of Clinimix and Clinimix E
    Baxter Announces U.S. FDA Approval of Clinimix and Clinimix E

    https://www.baxter.com/baxter-newsroom/baxter-announces-us-fda-approval-clinimix-and-clinimix-e-higher-protein-patients

    PRESS RELEASE
    23 Sep 2020
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    Fresenius Kabi USA's Generic Dextrose: Sodium Chloride Receives Approval In US
    Fresenius Kabi USA's Generic Dextrose: Sodium Chloride Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211211

    FDA
    17 Sep 2020
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    Fresenius Kabi USA's Generic Dextrose: Sodium Chloride Receives Approval In US
    Fresenius Kabi USA's Generic Dextrose: Sodium Chloride Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211221

    FDA
    17 Sep 2020
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    Fresenius Kabi USA's Generic Dextrose Potassium Chloride Receives Approval In US
    Fresenius Kabi USA's Generic Dextrose Potassium Chloride Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212346

    FDA
    15 Sep 2020
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    Fresenius Kabi USA's Generic Dextrose: Sodium Chloride Receives Approval In US
    Fresenius Kabi USA's Generic Dextrose: Sodium Chloride Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211276

    FDA
    15 Sep 2020
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    Fresenius Kabi`s Generic Dextrose ; Sodium Chloride Receives Approval in US
    Fresenius Kabi`s Generic Dextrose ; Sodium Chloride Receives Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211194

    FDA
    27 Aug 2020
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    Fresenius Kabi's Generic Dextrose and Sodium Chloride Receives Approval in US
    Fresenius Kabi's Generic Dextrose and Sodium Chloride Receives Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211190

    FDA
    21 Dec 2019
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    Enforcement Report - Week of November 14, 2018
    Enforcement Report - Week of November 14, 2018

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-november-14-2018-1542217134.pdf

    FDA
    14 Nov 2018
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    NovioSense Announces Positive Phase 2 Clinical Trial Results
    NovioSense Announces Positive Phase 2 Clinical Trial Results

    https://www.businesswire.com/news/home/20181025005032/en/NovioSense-Announces-Positive-Phase-2-Clinical-Trial

    BUSINESSWIRE
    28 Oct 2018
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    Enforcement Report - Week of October 3, 2018
    Enforcement Report - Week of October 3, 2018

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-october-3-2018-1538550050.pdf

    FDA
    03 Oct 2018
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    Fresenius Kabi USA’s Generic Dextrose Injectable Receives Approval In The US
    Fresenius Kabi USA’s Generic Dextrose Injectable Receives Approval In The US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209448

    FDA
    21 Jul 2018
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    Advanced Pharma, Inc. D/B/A Avella of Houston Issues Voluntary Nationwide Recall
    Advanced Pharma, Inc. D/B/A Avella of Houston Issues Voluntary Nationwide Recall

    https://www.pharmacompass.com/pdf/news/advanced-pharma-inc-dba-avella-of-houston-issues-voluntary-nationwide-recall-of-all-unexpired-nitroglycerin-injection-1497595684.pdf

    FDA
    16 Jun 2017
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    Top EU court bars Dextrose tablet maker's glucose health claims
    Top EU court bars Dextrose tablet maker's glucose health claims

    http://www.reuters.com/article/us-eu-court-dextroenergy-idUSKBN18Z19H

    Elizabeth Miles REUTERS
    08 Jun 2017
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    Hospira recalls injected dextrose for infants
    Hospira recalls injected dextrose for infants

    http://www.fiercepharma.com/manufacturing/hospira-recalls-injected-dextrose-for-infants-one-its-products-short-supply

    Eric Palmer FIERCE PHARMA
    31 May 2017
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    Anvisa suspends batch of generic Glucose 10%
    Anvisa suspends batch of generic Glucose 10%

    https://www.pharmacompass.com/pdf/news/anvisa-suspends-batch-of-generic-glucose-10-1493959888.pdf

    ANVISA
    04 May 2017
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    Eli Lilly updates Trulicity label to include use in combo with basal insulin
    Eli Lilly updates Trulicity label to include use in combo with basal insulin

    http://www.pharmabiz.com/NewsDetails.aspx?aid=100278&sid=2

    PHARMABIZ
    09 Feb 2017
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    Artificial insulin-producing cells may help manage diabetes
    Artificial insulin-producing cells may help manage diabetes

    http://www.financialexpress.com/lifestyle/health/artificial-insulin-producing-cells-may-help-manage-diabetes/471916/

    FINANCIAL EXPRESS
    12 Dec 2016
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    FDA Approves Sanofi's Combination Diabetes Drug
    FDA Approves Sanofi's Combination Diabetes Drug

    http://www.dddmag.com/news/2016/11/fda-approves-sanofis-combination-diabetes-drug?

    DDDMAG
    22 Nov 2016
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    Fresenius's Generic Dextrose Approved In US
    Fresenius's Generic Dextrose Approved In US

    https://www.pharmacompass.com/pdf/news/freseniuss-generic-dextrose-approved-in-us-1477391142.pdf

    FDA
    21 Oct 2016
    Share Share
    US FDA Enforcement Report- 1/June/2016
    US FDA Enforcement Report- 1/June/2016

    https://www.pharmacompass.com/pdf/news/us-fda-enforcement-report-1june2016-1464785216.pdf

    FDA
    31 May 2016
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    B. Braun Medical Issues Voluntary Nationwide Recall of Lot J5J706, 5% Dextrose Inj USP
    B. Braun Medical Issues Voluntary Nationwide Recall of Lot J5J706, 5% Dextrose Inj USP

    http://www.fda.gov/Safety/Recalls/ucm492927.htm

    FDA
    28 Mar 2016
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    Aurobindo Pharma gets FDA nod bacterial infection injection Dextrose
    Aurobindo Pharma gets FDA nod bacterial infection injection Dextrose

    http://www.indiainfoline.com/article/news-top-story/aurobindo-pharma-gets-fda-nod-bacterial-infection-injection-dextrose-116021100243_1.html?

    IIFL
    10 Feb 2016
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    Expanding the Analytical Toolbox for Identity Testing of Pharmaceutical Ingredients: Spectroscopic Screening of Dextrose Using Portable Raman and Near Infrared
    Expanding the Analytical Toolbox for Identity Testing of Pharmaceutical Ingredients: Spectroscopic Screening of Dextrose Using Portable Raman and Near Infrared

    http://www.pharma-excipients.ch/2016/02/07/expanding-the-analytical-toolbox-for-identity-testing-of-pharmaceutical-ingredients-spectroscopic-screening-of-dextrose-using-portable-raman-and-near-infrared-spectrometers/

    PHARMA-EXCIPIENTS
    08 Feb 2016
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    Baxter initiates Voluntary Nationwide Recall of Select Lots of IV Solutions Due to the Potential for Leaking Containers and Particulate Matter
    Baxter initiates Voluntary Nationwide Recall of Select Lots of IV Solutions Due to the Potential for Leaking Containers and Particulate Matter

    http://www.fda.gov/Safety/Recalls/ucm483147.htm

    FDA
    26 Jan 2016
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    Boston' sugardown in clinical trials reduces glucose, fructose and insulin
    Boston' sugardown in clinical trials reduces glucose, fructose and insulin

    http://cphi-online.com/boston-therapeutics-sugardown-in-clinical-trials-news038501.html

    CPHI ONLINE
    29 Dec 2015
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    Brief periods of standing, walking tied to better blood sugar
    Brief periods of standing, walking tied to better blood sugar

    http://www.reuters.com/article/us-health-diabetes-women-standing-idUSKBN0TX2NS20151214

    Andrew M. Seaman REUTERS
    14 Dec 2015
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    Recall: Baxter's Clinimix (2015-06-19)
    Recall: Baxter's Clinimix (2015-06-19)

    http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2015/53900r-eng.php

    HEALTHY CANADIANS
    12 Jun 2015
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    Fresenius Kabi USA, LLC initiates Class II recall of Kabiven Due to Label Error on Declared Strength
    Fresenius Kabi USA, LLC initiates Class II recall of Kabiven Due to Label Error on Declared Strength

    http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-1114-2015&w=06102015&lang=eng

    FDA
    10 Jun 2015
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    Hospira Initiates Class I Recall of Magnesium Sulfate in 5% Dextrose Injection
    Hospira Initiates Class I Recall of Magnesium Sulfate in 5% Dextrose Injection

    http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-1076-2015&w=05202015&lang=eng

    FDA
    21 May 2015
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    Drug shortages become issue in Teva and Mylan hook-up
    Drug shortages become issue in Teva and Mylan hook-up

    http://www.fiercepharmamanufacturing.com/story/drug-shortages-becomes-issue-teva-and-mylan-hook/2015-04-30

    Eric Palmer FIERCE PHARMA MANUFACTURING
    30 Apr 2015
    Share Share
    Baxter Initiates Voluntary Recall Due to the Presence of Particulate Matter
    Baxter Initiates Voluntary Recall Due to the Presence of Particulate Matter

    http://www.fda.gov/Safety/Recalls/ucm442074.htm

    FDA
    13 Apr 2015
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    Baxter Healthcare Corp, Ongoing Class II recall of Clinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose with calcium) Injection, 2000 mL in Dual Chamber Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- Product code 2B7722, NDC 0338-1125-04 because of Lack of Assurance of Sterility; increased complaints received for leaks
    Baxter Healthcare Corp, Ongoing Class II recall of Clinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose with calcium) Injection, 2000 mL in Dual Chamber Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- Product code 2B7722, NDC 0338-1125-04 because of Lack of Assurance of Sterility; increased complaints received for leaks

    http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-0428-2015&w=04082015&lang=eng

    FDA
    08 Apr 2015
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    Baxter Healthcare Corp., Ongoing Class II recall of 5% Dextrose Injection, USP, 1000mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0017-04 because of Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
    Baxter Healthcare Corp., Ongoing Class II recall of 5% Dextrose Injection, USP, 1000mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0017-04 because of Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.

    http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-0425-2015&w=04012015&lang=eng

    FDA
    01 Apr 2015
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    Hospira Inc., Ongoing Class II recall of 5% DEXTROSE Injection, USP, 250 mL ADD-Vantage Unit bag (NDC 0409-7100-04), UPC (01)003040971000040, packaged in 24 bags per case pack (NDC 0409-7100-02), UPC (01)30304097100027(30)01, Rx only, Hospira, Inc., Lake Forest, IL 60045. because of Lack of Assurance of Sterility: there is a potential for solution to leak at the administrative port of the primary container.
    Hospira Inc., Ongoing Class II recall of 5% DEXTROSE Injection, USP, 250 mL ADD-Vantage Unit bag (NDC 0409-7100-04), UPC (01)003040971000040, packaged in 24 bags per case pack (NDC 0409-7100-02), UPC (01)30304097100027(30)01, Rx only, Hospira, Inc., Lake Forest, IL 60045. because of Lack of Assurance of Sterility: there is a potential for solution to leak at the administrative port of the primary container.

    http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-0417-2015&w=03252015&lang=eng

    FDA
    25 Mar 2015
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    Dextrose 5% INJ 5 g /100 mL USP (2015-03-04)
    Dextrose 5% INJ 5 g /100 mL USP (2015-03-04)

    http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2015/52479r-eng.php

    HEALTHY CANADIANS
    09 Mar 2015
    Share Share
    0.9% Sodium Chloride Injection USP and 5% Dextrose Injection USP - Recalled Lot Due to the Potential for Leakage of the Parenteral Solution Bag
    0.9% Sodium Chloride Injection USP and 5% Dextrose Injection USP - Recalled Lot Due to the Potential for Leakage of the Parenteral Solution Bag

    http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2015/52431a-eng.php

    HEALTHY CANADIANS
    04 Mar 2015
    Share Share
    New Study Finds Toddler Foods Have High Salt And Sugar
    New Study Finds Toddler Foods Have High Salt And Sugar

    http://in.reuters.com/article/2015/02/02/us-baby-foods-salt-sugar-idINKBN0L61OD20150202

    Kathryn Doyle REUTERS
    02 Feb 2015
    Share Share
    Baxter Healthcare Corp., Ongoing Class II recall of Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injections, in CLARITY Dual Chamber Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-1115-04 because of Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal
    Baxter Healthcare Corp., Ongoing Class II recall of Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injections, in CLARITY Dual Chamber Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-1115-04 because of Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal

    http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-0301-2015&w=12242014&lang=eng

    24 Dec 2014
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