A recall by Hospira ($HSP) is not an unusual occurrence. The U.S. leader of sterile injectable drugs has had a consistent string of recalls for several years as it struggles to get manufacturing at key plants up to FDA standards. But it has been a particularly bad few days for the company, with both it and the FDA alerting healthcare providers of problems with multiple lots of its drugs. That was in addition to an alert for one of its medical products.
A notice today said that 15 lots of piperacillin and tazobactam, used to treat severe infections in some patients, were being recalled because they might crystallize in IV bags or IV lines after they are mixed into an injectable solution. Hospira manufactures the drugs, but they are marketed in the U.S. by Apotex, who issued the recall.
That followed Friday's nationwide notice that Hospira was recalling one lot of sodium chloride, a follow-up to a recall it first initiated 8 months ago after a customer saw four different particles in four different flexible containers. The company has since figured out that the particles were polyester fiber, nylon fiber, cotton fiber and nitrocellulose fiber, the notice explained. It said the company had not found any quality problems with retained samples but that the injection of fibers into a patient could lead to problems ranging from inflammation to a "granulomatous formation in the lungs." The company last month recalled a lot of sodium chloride after it discovered a bag containing copper particles; that recall followed at least three others this year.
Hospira has invested more than $375 million in upgrades and services in its manufacturing facilities in the last several years but has repeatedly had to recall products and adjust expectations for investors. It had three recalls of 5 products while inspectors were in its Rocky Mount, NC, plant earlier this year for a crucial re-inspection that the company hoped would show it was on top of problems. Instead, inspectors left a Form 483 with 20 more observations.
Earlier this month, the company named a new executive to take charge of its manufacturing and quality oversight. It was the second time in a year that the drugmaker had given a top executive that responsibility.
- here's one Hospira recall
- here's the other