|Ben Venue Laboratories--Courtesy of Ben Venue|
German drugmaker Boehringer Ingelheim closed its Ben Venue Laboratories contract manufacturing operations at the end of last year, but the legacy of the troubled plant lives on. According to an FDA release, Ben Venue is recalling a lot of acetylcysteine solution.
The voluntary recall was issued Friday after there was a report of a single visible glass particle in a vial in a lot. Acetylcysteine solution is used as a treatment in conditions like chronic emphysema and chronic asthmatic bronchitis and so is delivered via direct instillation into a tracheostomy, or into the bronchial-pulmonary tree during bronchoscopy. That means any glass particles in the solution pose a risk of choking or infection. The recall is being processed by Genco Pharmaceutical Services.
Recalls are nothing new for the facility. The sterile manufacturing plant in Bedford, OH, had such deep quality and sterility problems the it suspended operations in November 2011 and later had to sign a consent decree with the FDA. Because the facility was producing so many essential drugs, the FDA allowed it to continue to manufacture 100 products while it went through an extensive remediation.
Boehringer Ingelheim invested $350 million in upgrades at the facility, but in October the company said it had determined it made more business sense just to shut it down. Given the age of the plant, the "magnitude of continued investment and time required to overcome the systemic manufacturing challenges," it said it just was not viable. The drugmaker projected it would rack up $700 million in operating losses over 5 years to keep it open. Instead, the company started laying off its 1,100 employees and put the plant up for sale.
- here's the recall notice