- Boehringer Ingelheim’s (BI’s) Ohio plant was previously run by Ben Venue Laboratories. The main products manufactured at the plant were sterile injectables.
- Even though BI sold its Ben Venue Labs manufacturing plant to Hikma in July, the company is still responsible for recalling suspect products distributed through the facility.The latest product recall is part of a long series of Good Manufacturing Practice (GMP) violations.
- After a recent FDA inspection, BI is recalling 7,172 vials of CYTARAbine, a sterile injectable used to treat various blood cancers.
This latest recall is just the latest in a series of problems related to manufacturing at this site. In this instance, inspectors found crimp defects that could affect the integrity of container closure. Previous problems have included various sterility failures, as well as failure to meet hygiene standards.
The fallout from the plant's closure has been costly on several levels. Initially, BI considered shoring up the plant with a $350 million remediation investment. However, after the company determined that another $700 million would be needed just to bring the facility up to code, BI decided to sell the plant and was forced to lay off 1,100 employees in the process.
Jordan-based Hikma bought the facility as part of a larger $300 million deal in July and has no plans to reopen it. Instead, the company will move the newest equipment from the defunct plant to other plants in the U.S. and Europe.