Boehringer Ingelheim still being dogged by Ben Venue plant

Drugmaker recalls cancer drug over contamination concerns

August 29, 2014 | By Eric Palmer

Boehringer Ingelheim is finding it difficult to get the stink of the troubled Ben Venue Bedford, OH, operations off its shoes. It closed the site last year and sold it last month but is still having to recall products produced there that might be contaminated.

According to the FDA's weekly Enforcement Report, the German drugmaker is recalling two lots of CYTARAbine, an injected sterile drug for treating leukemia, acute myeloid leukemia and other cancers. The agency said the sterility of the 7,172 vials is suspect after a visual inspection found crimp defects that could affect the integrity of the container closure.

Boehringer Ingelheim closed the Bedford, OH, site at the end of last year and laid off about 1,100 workers after years of problems and dozens of product recalls. Ben Venue suspended most operations at the plant in November 2011 and later signed a consent decree with the FDA. The temporary closure resulted in more than 80 drug shortages. The drugmaker had poured about $350 million into upgrades but ultimately decided the payback was not going to be enough to make it worth keeping. It hung a For Sale sign on it and walked away.

Then Jordan-based Hikma, which has been building its sterile injectable operations, picked up the facility as part of a $300 million deal to buy the generic injectables business that Boehringer sold under its Bedford Laboratories brand. But Hikma has indicated it has no plans to reopen the facility. It is moving the newest equipment to plants in the U.S. and Europe.

This is not the first recall that Boehringer Ingelheim has had to make since the plant closed. In February it recalled a single lot of acetylcysteine solution after receiving a report of a visible glass particle in a vial. Acetylcysteine solution, used for conditions like chronic emphysema, is delivered via direct instillation into a tracheostomy or into the bronchial-pulmonary tree during bronchoscopy, so the glass poses a risk of choking or infection.