Lake Forest, IL
34 Class I recalls

When it comes to recalls, Hospira ($HSP) is in a class all of its own. With 34 over the period tabulated, it not only had the most, and three times more than the next closest, Baxter International, it actually had more than all the next 4 companies in this report put together. Its recalls ranged from cancer treatments like paclitaxel and methotrexate, to the narcotic morphine sulphate, and also included more mundane products like sodium chloride, or saline, the recalls of which have contributed to a national shortage of the essential solution.

On top of that, Canadian drugmaker Apotex had two Class I recalls of products it manufactured for Hospira. And remember, this is Class I recalls. There were many, many Class II and III recalls by Hospira over those years that are not included in the data.

The company said in a response that, "As we've progressed along our quality journey, we've also established stringent quality review and recall thresholds, which have resulted in higher recall rates." It also pointed out there have been an increase in recalls across the industry. But the company said it understands the impact that recalls have on customers. "One recall is one too many and through the company's investments and progress, we have seen an overall decrease in recalls in the last year."

Hospira CEO F. Michael Ball

Of course, Hospira's issues have become legendary in the industry. Problems at its Rocky Mount and Clayton, NC, plant were first noted in a warning letter investing. In response, it launched into an overhaul of its U.S. manufacturing operations, spending $375 million on consultants and upgrades, while CEO F. Michael Ball remade the quality-control team.

But the problems were deep and took longer than was expected to resolve, and its recall record was testament to the difficulty it was having getting things right. In 2013, even as inspectors were conducting a re-inspection of the Rocky Mount facility, Hospira had to recall 5 different products. The recalls have spanned the spectrum of possible problems. Some have been for leaky containers, others for labeling issues and many were for the presence of particulate that has included everything from rust to hair.

As it focused on its U.S. operations, problems popped up elsewhere in its manufacturing network. It received a warning letter for a plant in India in 2013 and last year the FDA savaged in a plant in Australia in a warning letter for not figuring out why tests showed the potency of cancer med mitoxantrone was too low and its impurities too high. The problems led Hospira to recall that drug. But the issues didn't stop there. On the last day of the first quarter this year, the FDA issued a warning letter for a Hospira plant in Italy.

It has made progress. It recently said that the FDA notified it that the agency would issue closeout letters for the plants in North Carolina. The decision comes too late for Clayton. Just weeks before announcing its $17 billion deal to be acquired by Pfizer ($PFE), the company said it had decided to shutter the Clayton plant in June and lay off most of the 200 workers.

Interestingly, from a recall standpoint, the numbers don't reflect that the situation is improving. According to the FDA data, Hospira had 8 Class I recalls in 2012 and then 7 in 2013. But in 2014, the company had twice that, 14 recalls. There were another 5 in the first quarter of 2015, putting it on track to top that number this year.

-- Eric Palmer (email | Twitter)

For more:
Hospira gets yet another warning letter, this one for Italy plant
Hospira recalls cancer med that was focus of warning letter
More FDA issues arise for Hospira in India
Hospira's Rocky Mount plant meets FDA goals, but one in India does not
Hospira issues 3 recalls as it faces crucial FDA inspection