Boehringer Ingelheim is still recalling products that were made at its Ben Venue plant in Bedford, OH, even though it no longer owns the massive site.
The German drugmaker is recalling two lots of CYTARAbine, an injected sterile drug for treating leukemia, acute myeloid leukemia and other cancers, according to the FDA's weekly Enforcement Report. A visual inspection found crimp defects in the container closure that make the sterility of the 7,172 vials suspect.
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. Last month, Jordan-based Hikma said it had taken on the site as a part of its $300 million deal to buy the generic injectables business that Boehringer sold under its Bedford Laboratories brand.
Hikma pointed out that the site has four manufacturing plants and a Quality and Development Center, which includes an R&D pilot plant and a team of experienced employees. But while the R&D folk interest Hikma, it said it was not going to reopen the manufacturing operations. Instead, it is moving the newest equipment to its plants in the U.S. and Europe.
While the plant is massive, so were its problems. Ben Venue suspended most operations at the plant in November 2011 after FDA inspectors tallied up a list of failings. It later signed a consent decree with the FDA, although it was allowed to keep manufacturing about 100 drugs because drugmakers had few options for alternative supplies. Even then, the temporary closure resulted in more than 80 drug shortages. Boehringer Ingelheim spent about $350 million to try to bring the facility up to FDA expectations but finally decided it was not worth it and closed the operation at the end of last year.
This is not Boehringer Ingelheim's first recall 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.
- here's the FDA recall notice