Hospira ($HSP), which has continued its struggles with manufacturing quality, closed out the year with a recall, and it was a big one. The Illinois-based company issued a worldwide recall of the cancer med mitoxantrone that was manufactured at a plant in Australia that the FDA savaged in a warning letter last year for not figuring out why tests showed its potency was too low and its impurities too high.
The drugmaker now is recalling 10 lots of the drug from the U.S., Canada, the U.K., Ireland, Australia, New Zealand, Cyprus, Saudi Arabia, Qatar, Oman and Bahrain. The recall is for both human and veterinary drugs in various dose sizes. The drug was distributed to hospitals and vet clinics globally starting in February 2013 and through November 2014, Hospira said in a release distributed by the FDA. The FDA said the Lake Forrest, IL, company figured out what caused the issue and addressed the problems for batches manufactured since March 2014.
The drugmaker said there have been no adverse reports from use of the cancer med, but acknowledged there is the potential for it not to be effective because of its subpotency and for patients then to receive additional dosing that could lead to toxin buildup from impurities.
The FDA in September took the drugmaker's plant in Mulgrave, Victoria, to task for not getting to the root cause of out-of-specification results for multiples batches of mitoxantrone, even after customer complaints. There was also a particularly long delay between when it first got word of particles appearing in the chemo drug carboplatin, in May 2012, and when it finally confirmed the issue, in December 2013. Then it was another three months before Hospira gave providers a heads up that they should be watching for particles and should use a filter before administering it, the letter said.
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| Hospira CEO F. Michael Ball |
The drugmaker has spent years, and hundreds of millions of dollars, working to get serious manufacturing failings at its U.S. plants behind it. And while those plants have improved, it has faced FDA concerns at facilities outside of the U.S. Besides the warning letter for the Australian plant, Hospira has had issues with operations in India, where it is expanding to lower its cost of products. A facility in Irungattukottai was issued a warning letter in May 2013 and then received another 23 observations in a follow-up inspection late that year. Last year, Hospira CEO F. Michael Ball told analysts that after a preapproval inspection of a plant it is building in Vizag, India, the FDA issued a Form 483 with 10 observations.
- here's the press release
- here's the FDA notice
- here's the warning letter for the Australian plant