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
    • Latest News
    • Torrent Pharma recalls...

    Torrent Pharma recalls over 10.78 lakh bottles of Losartan citing CGMP deviations

    Farhat NasimWritten by Farhat Nasim Published On 2019-04-22T11:51:58+05:30  |  Updated On 22 April 2019 11:51 AM IST
    Torrent Pharma recalls over 10.78 lakh bottles of Losartan citing CGMP deviations


    The US-based arm of Torrent Pharmaceuticals is recalling 133,992 bottles of Losartan Potassium tablets USP in the strength of 25 mg manufactured by the parent company at its Mehsana facility, the Enforcement Report of the USFDA said.



    New Delhi: Drug firm Torrent Pharmaceuticals Inc is recalling over 10.78 lakh bottles of hypertension treatment tablets from the US and Puerto Rico on account of deviations from current good manufacturing norms, as per a report of the US health regulator. The US-based arm of Torrent Pharmaceuticals is recalling 133,992 bottles of Losartan Potassium tablets USP in the strength of 25 mg manufactured by the parent company at its Mehsana facility, the Enforcement Report of the USFDA said.

    The company is also recalling 476,340 bottles of Losartan Potassium tablets USP, 50 mg from these markets, the United States Food and Drug Administration (USFDA) said.

    Torrent Pharmaceuticals Inc is recalling 121,668 bottles of Losartan Potassium tablets USP, 100 mg from America and Puerto Rico, it added.


    Also Read: Torrent Pharma gets USFDA observations for Dahej plant



    The company is also recalling multiple lots of Losartan Potassium / Hydrochlorothiazide tablets USP 50mg/12.5mg.In addition, 172,296 bottles of Losartan Potassium / Hydrochlorothiazide tablets, USP 100mg/12.5mg are being recalled, it added.

    Torrent Pharmaceuticals Inc is also recalling 173,760 bottles of these tablets in the strength of 100mg/25mg, the enforcement report said.

    All the ongoing voluntary recalls of the hypertension treatment drug are class II recalls, it added.

    The reason for the recalls is "CGMP Deviations: FDA lab confirmed the presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million", the report said.

    CGMP refers to the Current Good Manufacturing Practice regulations enforced by the USFDA.

    As per the USFDA, a class II recall 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".


    Also Read: Refix Ceiling Price of Torrent pharmas Trilosar 6.25, 12.5 : DoP directs NPPA


    cGMPcurrent good manufacturing practiceHydrochlorothiazideHydrochlorothiazide tabletshypertensionhypertension drugLosartanlosartan potassiumMEHSANAMehsana facilityMethylnitrosobutyricN Methylnitrosobutyricpharmapharma newspharma news indiarecalltorrent Mehsana facilityTorrent PharmaTorrent Pharmaceuticalstorrent recallUSFDA
    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

    Farhat Nasim
    Farhat Nasim

      Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751 To know about our editorial team click here

      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