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.
When the sterile injectables plant Hospira is building in Vizag, India, opens, perhaps yet this year, the company expects the 1.1-million-square-foot manufacturing facility to add capacity at a lower operating cost. But a plant of that size requires a lot of workers, and so Hospira is also making plans to train the people it needs there.
Hospira's reprieve from generic Precedex competition was short-lived. The U.S. district court that temporarily stopped Precedex generics has now decided to let the copycats roll. And that could mean Hospira will soon be sharpening its job-cutting ax.