Boehringer Ingelheim recalls cancer drug due to contamination issues

According to the FDA, Boehringer Ingelheim is recalling two lots of CYTARAbine, an injected sterile drug for treating leukemia, acute myeloid leukemia and other cancers that were made at its Ben Venue plant in Bedford. It closed the site last year but is still recalling products produced there that might be contaminated.

A visual inspection found crimp defects that could affect the integrity of the container closure which make the sterility of the 7,172 vials doubtful. Boehringer Ingelheim closed the Bedford site after years of problems and many 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.

In February, it also recalled a single lot of acetylcysteine solution after receiving a report of a visible glass particle in a vial. Acetylcysteine solution is 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.