Ben Venue is back in the news for product quality shortcomings with Europe's recommendation Friday of additional precautionary drug recalls. The European Medicines Agency issued a similar recall for drugs made at a troubled Ben Venue plant in late November.
The current recall recommendation is for batches of a Pfizer ($PFE) antifungal and a diagnostic agent because of potential contamination. In a statement, the EMA also asks doctors to inspect vials of a diluting agent used with Pfizer cancer drug Torisel, as well as vials of EpiCept's ($EPCT) Ceplene cancer drug, to check for particles.
A Dow Jones report says Pfizer has developed exit strategies for its drugs made by Ben Venue.
The EMA action comes two weeks after the agency's Nov. 28 recall recommendation for some cancer and antiviral drugs made at Ben Venue's Bedford, OH, plant. The EMA cited "shortcomings in the quality management system, particularly in relation to the aseptic filling process," in a previous announcement.
The EMA categorizes Ceplene, a leukemia treatment, and Torisel, a drug for kidney cancer, as essential because of the lack of other sources. The statement says doctors should check vials for particles.
Ben Venue, a unit of Boehringer Ingelheim, announced the shutdown of the plant Nov. 19. The company said in a statement that it was working on preventive maintenance and manufacturing equipment requalification that were overdue.
- here's the story
- here's the current EMA release
- and the earlier release