Fans of the pain reliever Excedrin are going to have to wait awhile longer for the popular over-the-counter pain reliever to fully return to store shelves. Production problems that forced the shutdown of the Nebraska plant that manufactures the drug have not been resolved, and will delay its reopening indefinitely.
Novartis (NYSE: NVS) had originally projected it would restart the plant by September, with some Excedrin products back in stores by late October. Earlier this week, the company said it “had resumed production” on a “line-by-line, product-by-product basis.”
But it looks like that’s not the case.
Novartis CEO Joseph Jimenez now admits the plant will not open later this year, after all. “What I would like to do is stop making projections because we have proven that we’re not able to accurately project,” he said.
“I’m still not happy with the progress that we’re making in Lincoln,” Jimenez said in a third quarter conference call with shareholders and analysts, according to a transcript in Seeking Alpha . ”So we are ensuring our return to market through third-party manufacturers, which will reduce our dependence on the remediation efforts at Lincoln.”
Issues at the troubled plant forced a voluntary recall of Excedrin in January after manufacturing problems led to bottles of Excedrin containing stray tablets from other Novartis products, or painkillers produced at the same plant.
That same facility was the subject of a Food and Drug Administration report earlier this year that said Novartis failed to open inspections into consumer complaints of foreign products found in medications. There were 26 such complaints in 2010 and 13 in 2009. The drug maker reportedly failed to investigate 166 complaints of foreign tablets in its medications since 2009.
The latest headaches caused by the Nebraska plant come on the heels of a ban of Novartis flu vaccines by the Italian health minister over concerns about side effects. Switzerland and Germany have also banned the flu vaccine, which is manufactured in Italy.
In the meantime, Novartis says it has been using outside contractors to make a products such as Excedrin Migraine, Triaminic and Lamisil. That will continue, said Brian McNamara, Division Head of Novartis, until the manufacturing problems are resolved.
“The Lincoln plant, as we look at the startup, is a sequential process that we talk line by line, product by product,” said McNamara. “So I won’t speculate on when we will be back, but that continues to be the focus at the plant.”
In a letter to Novartis employees last month, Jimenez addressed the continuing problems at the Lincoln plant, announcing a new companywide quality initiative with five key “quality behaviors.”
In his memo, Jimenez said employees are to think “always quality”, speak up for quality, jointly own problems, always ask “why” and build skills.
“I want our customers and regulators to know that each person at Novartis takes personal responsibility for quality,” he wrote.
Since the January recall, Novartis has seen a steady tumble in sales of its over the counter products, with a 22 percent drop in the most recent quarter, the fourth consecutive quarterly decline. Overall, sales were $938 million in the third quarter, down from $1.2 billion a year ago.