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.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug & Device Products
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Publications
    • Webinar Training Pass
    • eCFR and Guidances
    • Books
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Pfizer Recalls Lot of Xanax Over Out of Specification Result

Pfizer Recalls Lot of Xanax Over Out of Specification Result

pfizerlogo.gif
November 12, 2015

Pfizer has initiated a voluntary recall of a specific lot of its anxiety drug Xanax after stability testing yielded an out of specification result for an assay at the 46-month stability testing time point.

The affected Xanax (alprazolam) lot was shipped to pharmaceutical distributor Besse Medical between August 2011 and March 2012. The recall was deemed Class 2 by the FDA.

Pfizer has advised Besse to stop distributing the product and quarantine it immediately. It also requested that Besse forward a copy of the request to other wholesalers or retailers to which the drug was distributed.

Pfizer says the affected lot is not likely to cause adverse health consequences.

Pharmaceuticals Postmarket Safety

Upcoming Events

  • 08Sep

    Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections

  • 15Sep

    Califf’s Post-PDUFA, Post-COVID FDA Agenda: Key Developments, Insights and Analysis

  • 20Sep

    Building a World-Class Pharmaceutical Advertising and Promotion Review Program

  • 21Sep

    The FDA’s Focus on Clinical Data Integrity Throughout Product Development and Approval

  • 22Sep

    FDA’s New Quality Management System Regulation: What the Proposed Harmonization with ISO 13485 Means for Devicemakers

  • 11Oct

    1st Annual Quality Management vSummit

Featured Products

  • FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

    FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

  • MicroPort Navibot Receives 510(k) Clearance for Its SkyWalker System

  • FDA Expands Approval of Pfizer and Myovant’s Myfembree to Include Endometriosis

  • FDA Provides Update on Haimen Shengbang Laboratory’s Recall of Its Viral Transport Media Containers

  • FDA Issues EUA for Monkeypox Vaccine

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 – Toll free 888.838.5578

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing