Bristol-Myers Squibb Issues Voluntary Recall of Carmustine for Overfilled Vials - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Bristol-Myers Squibb Issues Voluntary Recall of Carmustine for Overfilled Vials


ePT--the Electronic Newsletter of Pharmaceutical Technology

Bristol-Myers Squibb Issues Voluntary Recall of Carmustine for Overfilled Vials

Bristol-Myers Squibb has initiated a voluntary recall nationwide of 10 lots of BiCNU (carmustine for injection) previously manufactured by Ben Venue Laboratories, a former, third-party contract manufacturer for the company, to the user level.

The precautionary recall of BiCNU, a chemotherapeutic agent administered to patients in a hospital or other clinical setting, is being initiated following the discovery of one overfilled vial of BiCNU during routine testing. “An overfilled vial of BiCNU represents a significant risk to patients due to the nature of product administration and could result in patients receiving a dose greater than prescribed,” said the company in an Aug. 31, 2012, press release. “There have been no reported adverse events associated with this issue.“

The recall is being conducted in the US, Canada, and countries within Europe, Latin America, and Asia-Pacific for lots previously manufactured by Ben Venue. Bristol-Myers Squibb does not anticipate a product shortage resulting from the recall because current supply is secured through another manufacturer.

Ben Venue announced last year that it was exiting the contract-manufacturing business following manufacturing quality issues at its facility. In December 2011, Ben Venue extended its voluntary suspension of its manufacturing activity at its Bedford, Ohio, facility, which it had first announced in November 2011. The original suspension took place after an internal review indicated that routine preventive maintenance and requalification of some manufacturing equipment was overdue. These issues was noted in inspection findings by FDA, EMA, and other global regulatory agencies. Ben Venue conducted a site-wide assessment to address these manufacturing issues, and in December 2011, indicated that it would resume production as it addressed facility and equipment issues.  

See related stories:

Ben Venue Continues Suspension of Manufacturing Activity at Ohio Facility (ePT, Jan. 5, 2012)

EMA Addresses Ben Venue Quality Issues (ePT, Dec. 15, 2011)

Ben Venue Suspends Manufacturing at Bedford Plant (ePT, Nov. 23, 2011)

Ben Venue Laboratories Exits Contract Manufacturing Business

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

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

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here