Bedford Labs – which is the generic injectables unit of Ben Venue - voluntarily recalled three lots of cytarabine last Thursday, explaining that the move was prompted by an inspection of the contract manufacturing organisation’s (CMO) production plant in Bedford, Ohio.
“This voluntary market recall is being conducted due to a post-release investigation of the manufacturing area which determined a potential elevated risk of a lack of sterility assurance for these specific lots” it said, stressing the move is a precautionary measure and that it has not received reports of any injuries caused by the drug.
Cytarabine is one of a number of cancer treatments made by Ben Venue to have been withdrawn in recent months. Ben Venue's position as a major global supplier meant that the previous recalls resulted in shortages of a number of key treatments, notably J&J’s Doxil (doxorubicin).
The problems started last year after regulators on both sides of the Atlantic voiced concerns about ‘quality management’ mechanisms at Ben Venue's plant in Bedford, Ohio. The CMO responded by halting manufacturing operations and launching a full investigation.
This was extended a few weeks later with Ben Venue citing the complexity of overhauling the various operations at all four manufacturing factories located at the Bedford, Ohio site as the main factor in the additional delay.
At the time it said: “As we address the facility and equipment issues in each factory, we will resume production, likely one line at a time. We are now working to restore some manufacturing in the first quarter of 2012, and will provide updates as they become available.”
As yet no updates have been provided.
The previous product recalls impacted a number of major drug industry customers, including J&J, GSK, Millennium, Celegene and – most recently – Genzyme which pulled nearly 10,000 vials of its leukaemia drug Fludara over similar sterility concerns last week.
What long-term impact, if any, the cytarabine recall will have on Ben Venue is unclear.
However, the firm will surely be keen to resume production as soon as possible given that – according to an announcement in August – it plans to wind up its contract manufacturing business and dedicate existing capacity solely to Bedford Labs' generic injectables portfolio.
Boehringer Ingelheim did not respond to Outsourcing-pharma.com's request for comment.