Divested sterile manufacturer Ben Venue has continued to cause trouble for Boehringer Ingelheim with a second recall this year of an injectable drug made at the now defunct site.
The contract manufacturing arm of Boehringer Ingelheim permanently halted production at its site in Bedford, Ohio in December 2013 after efforts to turn around its turbulent regulatory record were deemed too costly for the Germany-based owners.
However, despite being closed for nine months and Ben Venue’s assets being sold to Hikma last month, Boehringer Ingelheim is still suffering from the fallout of quality issues which led to a consent decree and this week initiated a recall of two lots of a chemotherapy agent made at the site.
The drug Cytarabine was made by the defunct manufacturer for its parent company Bedford Labs, bought by Hikma in May for $300m, and according to a US Food and Drug Administration (FDA) enforcement report was recalled due to the “lack of assurance of sterility,” after crimp defects were observed which could affect container closure integrity.
In February, Boehringer Ingelheim initiated a recall of a lot of inhalation drug Acetylcysteine made at the site, after the discovery of a single visible glass particle in a vial. Both Acetylcysteine and Cytarabine are on the World Health Organization's List of Essential Medicines.
Despite no longer owning or running Ben Venue, the responsibility for such recalls lie with Boehringer Ingelheim, according to spokesperson Kathy Vincent.
“Ben Venue’s highest priority is the quality and safety of the products it manufactured during its operations, and product that is in the market,” she told in-Pharmatechnologist.com. “Any voluntary recalls are conducted in accordance with FDA laws and regulations.”
With Hikma saying it would not be using its newly purchased facility for manufacturing purposes, and transferring machinery to other sites in its networks, we asked Vincent whether there were still ongoing business concerns between Ben Venue and its customers, other than recalls of drugs made from the site.
“No,” she said. “In August 2011, Ben Venue announced the exit from the contract manufacturing services business and has worked collaboratively with its former contract partners following this decision.”
The facility was at one stage the sole supplier of Janssen’s cancer drug Doxil, and manufacturing issues led to shortages of the drug. The announced closure of the site led Janssen’s parent company Johnson & Johnson to file a lawsuit attempting to reclaim 67 batches of Doxil the CMO had been contracted to make.
However, this was settled with the two firms reaching an agreement to allow Janssen to step in itself and take over manufacturing of its product for six months following Boehringer Ingelheim’s pullout.