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.