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Hospira manufacturing problems arise at an inopportune time

Drugmaker issues recalls as FDA inspectors conduct reinspection
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CEO F. Michael Ball

Hospira ($HSP) can't catch a break. CEO F. Michael Ball noted to analysts two weeks ago his excitement over FDA inspectors returning for a crucial reinspection of Hospira's beleaguered Rocky Mount, NC, plant. This week, while they were there, the company issued three recalls of 5 different products.

Hospira found visible particles embedded in the glass vials of propofol injectable emulsion, leading to the recall of three lots of that drug. It recalled one lot of preservative-free morphine sulfate injection after a customer found either a loose crimp or no crimp on the flip-top vial. That could result in contamination. It also recalled three lots of diazepam injection, furosemide injection, and Quelicin (succinylcholine chloride) injection for the same problem with loose crimping in flip tops.

The company said all of the recalls are voluntary and there have been no reports of patients being affected by any of the recalled products, although in each case there is a chance for serious effects.

The company launched into major upgrades after the FDA in 2011 found a long list of problems at plants in Rocky Mount and Clayton, NC; Austin, TX; and Boulder, CO. It had a bevy of recalls last year, and the plant interruptions have contributed to shortages of some crucial drugs. The company has allocated more than $375 million on remediation, including paying for tens of thousands of consultant hours.

Ball in his address to investors said the reinspection at Rocky Mount will affect whether the company believes it can ramp up production, sell more drugs and meet its financial projections. 

- the recalls are herehere and here (PDFs)

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