A loose hair has contributed to the nationwide shortage of saline solution, as Hospira recalls another lot of the commonly used product.
Hospira hopes to get back on track with its infusion pump business this year. The latest bit of good news for the company is FDA clearance for the Plum 360 Infusion System, which adds the capability to wirelessly stream data to an electronic medical record and access an expanded drug library for information to maintain patient safety.
Hospira is making cuts to its manufacturing network. The Lake Forest, IL-based drugmaker plans to close its facility in Clayton, NC, in June at a cost of up to 250 jobs and $15 million in severance payments and other employee-related costs.
Hospira vowed to cut old product lines, address its production problems and invigorate innovation in its medical devices business as part of a grand plan revealed on May 1, 2013. Now it's making some progress as it said FDA had lifted an import alert that had prohibited import of infusion pump devices manufactured in its Costa Rica plant.
Hospira is recalling another product manufactured at a plant in Australia which last year received an FDA warning letter. The Lake Forest, IL-based company is voluntarily recalling 3,306 vials of the cancer drug dacarbazine because of discoloration, according to the most recent FDA Enforcement Report.
Hospira, which has continued its struggles with manufacturing quality, closed out the year with a recall, and it was a big one. The Illinois-based company issued a worldwide recall of the cancer med mitoxantrone that was manufactured at a plant in Australia that the FDA savaged in a warning letter last year for not figuring out why tests showed its potency was too low and its impurities too high.
With FDA approval now in hand, Dyloject, an injectable nonsteroidal anti-inflammatory drug, could fill the void left by the expiration of most of the patents protecting Hospira's sedative, Precedex, which accounted for around 11% of the company's annual sales of $4 billion in mid-2014.
For months analysts have been handicapping who might buy Danone's medical nutrition business. Hospira was cited as a possible buyer for tax inversion reasons and then Fresenius was said to want it, but was getting frustrated with protracted talks. It turns out, after 8 months of speculation, that no one will get it.
In March, Hospira announced it had reached a $60 million agreement to settle a three-year-old lawsuit that said investors had been kept in the dark about the quality problems at its manufacturing operations. But another suit was filed last June, and now the Lake Forest, IL, company says it has been rolled into the settlement.
Amid growing industry concern over the cybersecurity of medical devices, the U.S. government is weighing in on the issue and investigating two dozen cases of suspected cybersecurity flaws in devices and hospital equipment.