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
    • Novartis recalls three...

    Novartis recalls three lots of Promacta due to potential peanut contamination

    Farhat NasimWritten by Farhat Nasim Published On 2019-05-14T10:00:40+05:30  |  Updated On 14 May 2019 10:00 AM IST
    Novartis recalls three lots of Promacta due to potential peanut contamination

    New Delhi: Novartis recently announced a voluntary recall of three lots of Promacta (eltrombopag) 12.5 mg for oral suspension to the consumer level. The oral suspension lots are being recalled because of a risk of potential peanut flour contamination that occurred at a third-party contract manufacturing site.


    Promacta tablets in 12.5 mg, 25 mg, 50 mg and 75 mg strengths are not impacted by this recall and are not manufactured in the same facility.


    Peanut is a known food allergen. Potential cross contamination with peanut flour, even in small traces, can lead to hypersensitivity reaction in a population of patients with an unknown or known sensitivity to peanut antigen, including a medically significant anaphylactic reaction, which can be fatal.


    To date, Novartis has not received any reports or adverse events for this recall.


    Promacta 12.5 mg for oral suspension was distributed nationwide through speciality pharmacies. The affected product name, including the lot numbers and expiration dates, include:




    • Promacta for Oral Suspension, Lot 8H57901589, expiration 09/2020

    • Promacta for Oral Suspension, Lot 9H57900189, expiration 12/2020

    • Promacta for Oral Suspension, Lot 9H57900289, expiration 12/2020


    Promacta 12.5 mg for oral suspension is indicated for the treatment of certain adult and pediatric patients with chronic immune thrombocytopenia, certain adult patients with hepatitis C-associated thrombocytopenia, and certain adult and pediatric patients with severe aplastic anemia who have not received prior immunosuppressive therapy or had an insufficient response to immunosuppressive therapy.


    Consumers who have impacted product with these lot numbers and NDC numbers in their homes should contact 1-866-918-8772 (8:00 AM – 5:00 PM EST, Monday through Friday) for instructions on how to return recalled product. For all additional questions, please contact Novartis at 1-888-NOW NOVA (8:30 AM – 5:00 PM EST, Monday through Friday).


    Consumers should stop taking Promacta 12.5 mg oral suspension and consult with their healthcare provider. Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.


    Pharmacies that have impacted product with these lot numbers and NDC numbers should contact 1-866-918-8772 (8:00 AM – 5:00 PM EST, Monday through Friday) for instructions for return of the recalled product.


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

    allergenanemiaaplastic anemiaeltrombopagimmunosuppressive therapyNovartisOral Suspensionpeanut butterpeanutsPromactarecallthrombocytopeniaUS

    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