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.
Hospira, the country's largest producer of sterile drugs, is recalling two dozen lots of saline solution, along with 30 lots of other products, because the bags on one of its delivery systems can leak and products might get contaminated.
Hospira is recalling "certain lots of several products in its LifeCare line of flexible intravenous solutions due to the potential for leakage." But the description does not get to the depth and breadth of the recall, which is for 54 lots of nearly a dozen products. That includes two dozen lots of saline solution in the 1000-mL size, an essential hospital product that has been in short supply for months.
BOSTON-- Whether through collaboration with academia or buyouts of smaller players, panelists at the Partnership Opportunities in Drug Delivery conference concurred that Big Pharma is increasingly looking externally for innovation and using its size and financial to power candidates through clinicial and onto the market.
Not all drug recalls track back to quality issues during manufacturing. A glitch in the supply chain can also come into play, and that is what happened with a lot of vancomycin hydrochloride injection being recalled by Hospira.
Hospira has been dealing with FDA concerns for years for plants in the U.S. and more recently in India. But despite being told more than a year ago that it should have a "global corrective action plan" for both its foreign and U.S. plants, new issues have surfaced, this time for a plant in Australia that makes specialty injectable drugs.
Hospira's FDA woes have moved to Australia. The agency scolded the U.S.-based company in a warning letter based on an injectables plant inspection in late February and early March, according to a Wednesday securities filing.
About three months before Hospira closed on its acquisition of an API plant from India's Orchid Chemicals & Pharmaceuticals, FDA inspectors made a visit to the facility in Waluj. They had concerns with what they found.
A loose hair has again tripped up Hospira, which is voluntarily recalling one lot of heparin as a result.