Cubist Pharmaceuticals Issues Recall Due to Glass Particles in Vials - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Cubist Pharmaceuticals Issues Recall Due to Glass Particles in Vials


Cubist Pharmaceuticals, Inc. announced on April 18 that it is voluntarily recalling one lot of CUBICIN (daptomycin for injection) to the user level due to the presence of particulate matter, reported via customer complaint and identified as glass particles, found in a single vial from this lot, produced by a contract manufacturer.

An internal investigation has identified the root cause as a manufacturing issue with a single manufacturing line of one of the company’s suppliers, and Cubist has suspended all manufacturing on this line, according to a company statement.

No adverse events have been reported to date in association with a product complaint of vials containing glass particulate.

The affected product was CUBICIN (daptomycin for injection) 500 mg NDC 67919-011-01; UPC 3 67919-011-01 6; Lot No. 280453F; expiration date of April 2016 and ship dates of March 17-24, 2014.

The company reports that it is notifying customers by letter and phone.

Sources:
FDA
Cubist Pharmaceuticals


 

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
23%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
7%
All of the above.
47%
No government involvement in patient treatment or drug development.
9%
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality

Click here