Hospira ($HSP) has been upgrading plants where the FDA found serious problems and getting production slowly ramped back up. CEO F. Michael Ball has suggested that investors should not let its remediation efforts overshadow the company's prospects. But despite the investments and the upgrades, the sterile injectables maker has found itself again recalling a product that might contain mold and so is potentially dangerous to patients.
The company says it is voluntarily recalling a single lot of Lactated Ringers and 5% dextrose injection after confirming a customer report that it contained "a spore-like structured particulate, consistent with mold." No adverse effects have been reported, but Hospira pointed out that if contaminated, its use could cause "thrombosis, phlebitis, bacteremia, sepsis, septic shock and/or endocarditis, or result in a fatal infection in a broad array of patients."
In an emailed statement to FiercePharmaManufacturing, the company said, "There have been no adverse events associated with this issue and we are conducting the recall voluntarily out of an abundance of caution. The action is due to one confirmed customer report, and we continue to investigate root cause. We haven't found the issue in retained samples from the same lot."
Hospira has made extensive improvements throughout its manufacturing system after the FDA in 2011 found a long list of problems at plants in Rocky Mount and Clayton, NC; Austin, TX; and Boulder, CO. Its manufacturing foul-ups contributed to such problems as overfilled drug injectors and particulates in vials. In July, it recalled 19 lots of four injectable cancer drugs shipped throughout the U.S. and other drugs shipped to about 15 countries around the world. Recalls and the supply interruptions have resulted in shortages of a number of drugs.
The upgrades have taken longer and cost more than the company projected and are now expected to top out at more than $375 million. But Ball has said the improvements will make the plants more efficient and improve Hospira's competitive position. The company expects an FDA inspection in the first half of this year at its Rocky Mount plant, which could provide it with a clean bill of health and the confidence to crank up production to preremediation levels.
- here's the FDA recall release
Editor's note: Story updated with statement from Hospira.