A month after Hospira ($HSP) CEO F. Michael Ball acknowledged the company had more work to do to get its various manufacturing issues in hand, the company has recalled a product after hair was found in an injector.
|Hospira CEO F. Michael Ball|
The Lake Forest, IL-based company is recalling one lot of its parenteral nutritional product Aminosyn II 10%, sulfite-free, 500mL. It said a customer found an unknown foreign particle in contact with product in the injection port. Hospira confirmed that it was human hair. No adverse events have been reported, and the voluntary recall is precautionary. The company has yet to figure out the root cause of the problem.
Hospira has invested hundreds of millions of dollars on upgrades and consultants, trying to reach a place where it can produce without the constant quality issues that have plagued it in recent years. On its second-quarter earnings call, execs said Hospira has spent about $45 million on remediation and consultants already this year, down from $114 million in the first 6 months of 2012. It said it expected to spend about $100 million this year on work at both drug and device facilities. The company has been able to ramp up production and reduce backlogs, but Ball acknowledged the company still has "work to do to reinforce our foundation."
The company is not the only drugmaker to recently have to recall product because of visible particulate. Soliris' maker Alexion ($ALXN) two weeks ago said it was recalling the final vials of one lot of the orphan drug from international markets because of particles detected in some of them.
- here's the release
CEO says Hospira is making progress on manufacturing fixes
Hospira issues 3 recalls as it faces crucial FDA inspection
Alexion recalls some Soliris vials from international markets