Hospira ($HSP), which has been trying so hard to make improvements in its manufacturing and quality-control methods in the face of plant problems, has had to recall another lot of medication, this time syringes believed to contain too much of a pain killer.
A release from the company posted on the FDA website says Hospira voluntarily recalled a single lot of hydromorphone injection Carpuject after receiving two reports that single-filled cartridge used in the Carpuject contained more than the 1 mL labeled fill volume.
The medication was distributed in September and October last year to wholesalers and some hospitals in 18 states and Washington, DC, according to the release. There have been no reports of any adverse effects.
Just last month, the company announced a similar voluntary recall after getting a couple of reports of Carpuject syringes containing too much morphine sulfate, another pain drug, Dow Jones reports. Both products are manufactured on the same production line, so the potential problem leading to the current recall was discovered during an investigation into the first, the news service says.
During its earnings call two weeks ago, Hospira disclosed that a problem in manufacturing led to the temporary shutdown of production of the sedative propofol at its Clayton, NC, plant. It said supplies might be disrupted as a result.
The problems are surfacing during a particularly sensitive time for Hospira, which has been in the midst of remediation efforts for months at plants in Austin, TX, and Clayton and Rocky Mount, NC. The Rocky Mount plant closed in December for maintenance and then resumed production in January after the company threw extensive resources at fixing the problems. The plant is currently operating at 60% to 70% production and will remain there at least through mid-year. During its earnings call, executives said they believed FDA concerns at the Austin plant had all been addressed.
The company also has announced a number of management changes intended to bring more expertise to manufacturing across all of its operations.
- read the Dow Jones report