Sterile drugmaker Hospira ($HSP) recently recalled a lot of a parenteral nutritional product after a human hair was found in it. Now, the drugmaker is expanding a voluntary, nationwide recall of bupivacaine injection because particles of stainless steel and iron oxide were found in some vials.
The drugmaker in July initiated the first recall, but the FDA sent out an alert Monday that the recall has been extended to include a second lot of the anesthesia. The alert says both recalls "are due to confirmed customer reports of particulate floating and/or embedded in the glass vial. The particulate was identified as stainless steel ranging in size from 542 microns to 1,700 microns in lot 18-136-DK (0.25% bupivacaine) and as iron oxide with an average size of 2,000 microns in lot 23-338-DK (0.75% bupivacaine)." Both products are packaged in glass teartop vials, 25 units to a carton and 50 units to a case. The company said there have been no reports of adverse events.
Hospira makes a lot of products, and so some recalls can be expected. But Hospira has invested hundreds of millions of dollars on plant upgrades and consultants, trying to reach a place where it can produce without the constant quality issues that have plagued it in recent years. The company has spent about $45 million on remediation and consultants already this year, down significantly from the $114 million it spent in the first 6 months of 2012. It is projected to spend about $100 million this year on work at both drug and device facilities.
Much of the money has been spent on its key plant in Rocky Mount, N.C. Earlier this year, while FDA inspectors were in the facility for a reinspection that CEO F. Michael Ball hoped would essentially clear the plant, the company had three recalls. The inspection resulted in another Form 483 for Hospira. Since then, Hospira has indicated it is making progress. The company has been able to ramp up production and reduce backlogs, but Ball has acknowledged the company still has "work to do to reinforce our foundation."
- here's the recall notice