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    Enforcement Report - Week of August 25, 2021
    Enforcement Report - Week of August 25, 2021

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-august-25-2021-1629867988.pdf

    FDA
    25 Aug 2021
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    Gland Pharma's Generic Haloperidol Decanoate Receives Tentative Approval in US
    Gland Pharma's Generic Haloperidol Decanoate Receives Tentative Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205241

    FDA
    29 Oct 2019
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    Zydus Healthcare's Generic Haloperidol Decanoate Receives Approval in US
    Zydus Healthcare's Generic Haloperidol Decanoate Receives Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211180

    FDA
    25 Oct 2019
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    Cadila Healthcare gets USFDA nod for Haloperidol Decanoate injection
    Cadila Healthcare gets USFDA nod for Haloperidol Decanoate injection

    https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/cadila-healthcare-gets-usfda-nod-for-haloperidol-decanoate-injection/articleshow/71735452.cms

    ECONOMIC TIMES
    24 Oct 2019
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    Somerset Theraps LLC’s Generic Haloperidol Decanoate Receives Approval In The US
    Somerset Theraps LLC’s Generic Haloperidol Decanoate Receives Approval In The US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209101

    FDA
    09 Jul 2018
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    Gland Pharma’s Generic Haloperidol Decanoate Receives Approval In US
    Gland Pharma’s Generic Haloperidol Decanoate Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205241

    12 May 2017
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    Mylan Institutional LLC, Ongoing Class II recall of Haloperidol Decanoate Injection, 100 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-409-00) packaged in cartons of five (NDC 67457-409-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103 because of Lack of Assurance of Sterility; due to leaking vials
    Mylan Institutional LLC, Ongoing Class II recall of Haloperidol Decanoate Injection, 100 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-409-00) packaged in cartons of five (NDC 67457-409-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103 because of Lack of Assurance of Sterility; due to leaking vials

    http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-0421-2015&w=04012015&lang=eng

    FDA
    01 Apr 2015
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    Mylan Institutional LLC, Ongoing Class II recall of Haloperidol Decanoate Injection, 50 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-410-00) packaged in cartons of ten (NDC 67457-410-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103 because of Lack of Assurance of Sterility; due to leaking vials
    Mylan Institutional LLC, Ongoing Class II recall of Haloperidol Decanoate Injection, 50 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-410-00) packaged in cartons of ten (NDC 67457-410-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103 because of Lack of Assurance of Sterility; due to leaking vials

    http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-0422-2015&w=04012015&lang=eng

    FDA
    01 Apr 2015
    Share Share
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