Sterile injectables maker Hospira ($HSP) is having to recall lots of 5 different products even as FDA inspectors are in one of its plants conducting what the company hopes will be a final inspection that will return the drugmaker to the agency's good graces.
Over the last several days, Hospira recalled three lots of propofol injectable emulsion after reports came to light that some vials had visible particles embedded in the glass. These were found in some retained samples. It is recalling one lot of preservative-free morphine sulfate injection after a customer found either a loose crimp or no crimp on the flip-top vial, which raises the possibility of contamination. It also recalled three lots of diazepam injection, furosemide injection and Quelicin (succinylcholine chloride) injection for the same problem with loose crimping in flip tops.
The company said all of the recalls are voluntary and there have been no reports of patients being affected by any of the recalled products, although in each case there is a chance for serious effects.
During its earnings call two weeks ago, Hospira CEO F. Michael Ball said that FDA inspectors had returned to its beleaguered Rocky Mount, NC, plant and that he was excited that it was finally happening. He told analysts that projections for the year were dependent on expectations that its upgrades get the FDA's approval so the company would feel comfortable increasing production there. It later altered its projections because of issues the FDA has at a medical-device plant.
The company launched into major upgrades after the FDA found a long list of problems at plants in Rocky Mount and Clayton, NC; Austin, TX; and Boulder, CO, in 2011. It had a bevy of recalls last year, and the plant interruptions have contributed to shortages of some crucial drugs. The company has allocated more than $375 million on remediation, including paying for tens of thousands of consultant hours.
The company has had to recall any number of products during the last year as it has been making improvements and working closely with the agency on its plans of action.
- the recalls are here, here and here (PDFs)