Business Medical Dialogues
    • facebook
    • twitter
    Login Register
    • facebook
    • twitter
    Login Register
    • Medical Dialogues
    • Speciality Dialogues
    • Education Dialogues
    • Medical Jobs
    • Medical Matrimony
    • MD Brand Connect
    Business Medical Dialogues
    • News
        • Financial Results
        • Hospitals & Diagnostics
        • IT / Health Venture
        • Implants / Devices
        • Insurance
        • Key Movement
        • Pharmaceuticals
        • Policy
        • Technology
        • pharma-news
    • blog
    LoginRegister
    Business Medical Dialogues
    LoginRegister
    • Home
    • News
      • Financial Results
      • Hospitals & Diagnostics
      • IT / Health Venture
      • Implants / Devices
      • Insurance
      • Key Movement
      • Pharmaceuticals
      • Policy
      • Technology
      • pharma-news
    • blog
    • Home
    • Editors Pick
    • Sun Pharma recalls 3.8...

    Sun Pharma recalls 3.8 lakh cartons of Osteoporosis drug in US

    Written by savita thakur thakur Published On 2016-03-11T12:47:08+05:30  |  Updated On 11 March 2016 12:47 PM IST
    Sun Pharma recalls 3.8 lakh cartons of Osteoporosis drug in US
    New Delhi: Around 3.8 lakh cartons of an osteoporosis drug manufactured by domestic drug major Sun Pharmaceutical Industries are being recalled in the US and Puerto Rico due to presence of 'unknown impurity'.

    The recall of 3,81,120 cartons of Alendronate Sodium tablets has been initiated by Sun Pharma Global Fze, an arm of the Indian pharma major.

    The drug is manufactured at Sun Pharma's Halol facility in Gujarat, United States Food and Drug Administration (USFDA) said in its latest Enforcement Report.

    The cartons are being recalled on account of "observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point," the report said.

    The ongoing recall falls under Class II, which is initiated "in a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote," it said.

    Alendronate Sodium tablets are used for treatment of osteoporosis in postmenopausal women.

    Last year in December, Sun Pharma had said it had received a warning letter from the USFDA over violation of manufacturing norms in its facility at Halol in Gujarat and the US health regulator had withheld future product approvals from the facility.

    Source: PTI
    Alendronate Sodium tabletsosteoporosis drugPuerto RicoSun Pharma Global FzeSun PharmaceuticalUnited States Food and Drug AdministrationUSFDA
    Source : PTI

    Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd

    savita thakur thakur
    savita thakur thakur
      Show Full Article
      Next Story
      Similar Posts
      NO DATA FOUND

      Popular Stories

      • Email: info@medicaldialogues.in
      • Phone: 011 - 4372 0751

      Website Last Updated On : 13 Oct 2022 5:14 AM GMT
      Company
      • About Us
      • Contact Us
      • Our Team
      • Reach our Editor
      • Feedback
      • Submit Article
      Ads & Legal
      • Advertise
      • Advertise Policy
      • Terms and Conditions
      • Privacy Policy
      • Editorial Policy
      • Comments Policy
      • Disclamier
      Medical Dialogues is health news portal designed to update medical and healthcare professionals but does not limit/block other interested parties from accessing our general health content. The health content on Medical Dialogues and its subdomains is created and/or edited by our expert team, that includes doctors, healthcare researchers and scientific writers, who review all medical information to keep them in line with the latest evidence-based medical information and accepted health guidelines by established medical organisations of the world.

      Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription.Use of this site is subject to our terms of use, privacy policy, advertisement policy. You can check out disclaimers here. © 2025 Minerva Medical Treatment Pvt Ltd

      © 2025 - Medical Dialogues. All Rights Reserved.
      Powered By: Hocalwire
      X
      We use cookies for analytics, advertising and to improve our site. You agree to our use of cookies by continuing to use our site. To know more, see our Cookie Policy and Cookie Settings.Ok