Last December, a little-known compounding pharmacy recalled all of its products due to “process issues that could lead to a lack of sterility,” according to a statement issued at the time by the U.S. Food and Drug Administration.
Now, the extent of those problems has been made clear after the agency posted a 28-page report by its inspectors, who last fall found a plethora of filthy conditions at a facility run by Edge Pharma, which compounds numerous medicines for hospitals, surgery centers, and clinics for more than a dozen different therapeutic areas including urology, ophthalmology, and neurology.