We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Device Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Sagent Pharmaceuticals Pulls Blood Pressure Drug Over Sterility Snag

Sagent Pharmaceuticals Pulls Blood Pressure Drug Over Sterility Snag

March 18, 2021

Sagent Pharmaceuticals has recalled three lots of its phenylephrine hydrochloride injection, manufactured by partner Indoco Remedies, because of sterility concerns.

The product in question had a possibly loose vial seal that could result in the drug becoming nonsterile, the FDA said, adding that a nonsterile product could lead to a life-threatening infection.

The drug is an alpha-1 adrenergic receptor agonist used to treat low blood pressure caused by blood vessel dilation during the administration of anesthesia. Sagent has not received any adverse event reports to date, the agency said.

View today's stories

Pharmaceuticals Postmarket Safety

Upcoming Events

  • 15Apr

    Five Telltale Signs You’re Ready for an Electronic TMF System

  • 21Apr

    CDER’s Most Significant Guidance Priorities for 2021: Biosimilars/Biologics, Generics/Exclusivity, Real-World Evidence, Drug Development and Digital Health

  • 26Apr

    MAGI's Clinical Research vConference — Spring 2021

  • 06May

    The World of Post-COVID-19 Clinical Trials: How to Prepare for What’s Coming Next

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • CE mark

    Roche Receives CE Mark for Elecsys Cancer Test

  • team up

    Biogen and Bio-Thera Solutions Partner Over Actemra Biosimilar

  • FDA logo blue

    Former Indivor Executive Seeks FDA Hearing to Avoid Debarment

  • FDA clears text

    FDA Clears Activ Surgical’s Imaging Module for ActivEdge Platform

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing