• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • Clinical Trial Listings
    • What are Clinical Trials?
    • Become a Clinical Trial Volunteer
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Market Research
    • Benchmark Reports
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
  • White Papers
  • Clinical Trial Listings
  • Advertise
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Sun Pharma recalls another drug at plant in Halol

Sun Pharma recalls another drug at plant in Halol

September 3, 2015
CenterWatch Staff

A Sun Pharma plant that already has been a problem for the FDA has to recall another product that the Indian pharmaceutical said failed dissolution testing.

The most recent FDA Enforcement report states that the Mumbai, India-based Sun is voluntarily recalling three lots of bupropion hydrochloride extended-release tablets manufactured at its plant in Halol, located in Gujarat, India. According to Sun, the drug failed dissolution testing at 18 months because its drug-release results were not on the mark at the four-hour time point. The company is recalling more than 35,000 bottles of its generic of the antidepressant Wellbutrin XL.

In August, Sun blamed a 4% drop in its U.S. sales for the last quarter primarily on “temporary supply constraints arising from remediation efforts at the Halol facility.” The remediation initially began after the FDA issued a Form 483 to the plant after an inspection there last year, and the supply constraints can be connected in part to the recalls that the pharmaceutical has made of drugs produced at the facility.

Last year, Sun’s Halol plant retrieved more than 26,000 bottles of venlafaxine hydrochloride extended-release tablets, a generic of Pfizer’s Effexor XR, after it discovered that the tablets did not dissolve properly. Previously, it recalled more than 250,000 bottles of venlafaxine and more than 128,000 bottles of the decongestant cetirizine for the same reason.

The work at the Halol facility is only part of the extensive remediation work by Sun as it also attempts to bring back to FDA standards four other Indian plants that it obtained this year in its $4 billion buyout of Ranbaxy Laboratories. Those plants have been prevented from selling in the U.S. for years after the FDA found significant problems with them.

    Upcoming Events

    • 05Dec

      Thriving in Clinical Research – Overcoming Common Challenges as a Site: Part 3 – Site Resourcing

    • 14Apr

      MAGI 2024: The Clinical Research Conference

    Featured Products

    • Surviving an FDA GCP Inspection

      Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

    • Best Practices for Clinical Trial Site Management

      Best Practices for Clinical Trial Site Management

    Featured Stories

    • Jonathan Seltzer

      Thought Leadership: Remote Patient Monitoring Gives New View of Safety in Cardiac Clinical Trials

    • Quality_Compass-360x240.png

      Ask the Experts: Applying Quality by Design to Protocols

    • Obesity Treatment Patient

      Clinical Trials Need Greater Representation of Obese Patients, Experts Say

    • Modernize-360x240.png

      FDA IT Modernization Plan Prioritizes Data-Sharing, AI, Collaboration and More

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell or Share My Data

    Footer Logo

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

    Phone 703.538.7600 – Toll free 888.838.5578

    Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing