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 » Another Nine Lots of Cubicin Recalled by Cubist

Another Nine Lots of Cubicin Recalled by Cubist

August 19, 2014

Complaints of particulates found in vials of nine lots of Cubist Pharmaceuticals’ anti-infective drug Cubicin prompted the company to initiate its second recall of the drug in as many days.

The affected lots were distributed between July and December of last year. Although no adverse events have been reported, Cubist says particulates could potentially lead to a life-threatening embolism, blockage of capillaries or inflammatory responses.

This latest Cubicin recall comes on the heels of an Aug. 6 recall of 101 lots with possible glass particles stemming from an issue with a single production line that the company has since closed down.

While Cubist is still investigating the nature and source of the latest particulates, spokeswoman Julie DiCarlo said that none of the particulates appear to be glass and the company does not suspect that a manufacturing problem is the cause.

Anyone in possession of affected lots of the drug can contact Cubist to arrange to return the product and receive a replacement.

Cubicin (daptomycin injection) is indicated to treat certain skin and blood infections. — Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.

Pharmaceuticals Submissions and Approvals

Upcoming Events

  • 27Jan

    Medical Device Clinical Trials in China: Latest Regulatory Developments

  • 27Jan

    FDA’s Response to COVID-19: Fundamentals of Obtaining Emergency Use Authorizations

  • 09Feb

    Maintaining Your Risk-Based Cleaning and Disinfectant Programs: Best Practices During COVID-19

  • 10Feb

    FDA Under the Biden Administration: What’s to Come and What It Will Mean

  • 11Feb

    Lab X.0: Addressing Quality and Compliance Challenges in Laboratory Operations in the COVID-19 All-Digital Era

  • 17Feb

    Effective Auditing for Manufacturing Quality

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • Regeneron logo

    Regeneron’s Antibody Cocktail Shows Efficacy as COVID-19 Treatment

  • Mobile apps client cellphone cell phone

    FDA to Review Berkshire’s 510(k) Submission for Remote Drug-Delivery System

  • COVID-19

    Desidustat Improves Oxygenation for Hospitalized COVID-19 Patients

  • abbott-logo.gif

    Abbott’s Panbio COVID-19 Test Gets Additional CE Marks

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