UPDATED: Novartis OTC unit has another foul-up

Swiss drugmaker recalls 4.4 million bottles of Maalox
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Novartis ($NVS) has repeatedly had to deal with issues at its over-the-counter plant in Lincoln, NE, and once again has been bitten by problems there. This time, the company is recalling more than 4.4 million bottles of Maalox from the U.S. and Canada because of problems with packaging.

The Swiss drugmaker began the recall several weeks ago, and it encompasses 9 different types of its Maalox chewable tablets, including more than 3.4 million bottles of Maalox Advanced Maximum Strength Antacid & Antigas. According to the most recent FDA Enforcement report, the bottles may be missing a lot number or expiration date or those identifiers may be illegible on the outer plastic bottle packaging.

A Novartis spokeswoman said in an email that "the Maalox products being recalled were manufactured at the Novartis Consumer Health manufacturing facility in Lincoln, NE, before December 2011. We are restarting the plant on a line-by-line, product-by-product basis, taking the necessary time to validate all new processes to ensure control and adherence to a high standard of quality."

She said the plant resumed shipping  Novartis' Sentinel animal health product in April. The company also has had contractors making Excedrin, Lamisil AT and Triaminic, as well as most recently Benefiber, which began shipping to U.S. customers in late June 2013, she said.

The Lincoln OTC plant has been a source of frustration for CEO Joseph Jimenez since 2011, when FDA inspectors excoriated it for the mess there. It was Novartis' largest OTC manufacturing facility, producing its entire Excedrin line, as well as NoDoz, Bufferin and Gas-X Prevention products. It also made some branded drugs for other companies. Poor manufacturing forced it to recall millions of bottles of its popular OTC brands and then see revenues undercut by their absences from retail shelves. Fed up, Jimenez in April said the company would "simplify the Lincoln manufacturing plant" to focus on just two product forms--solids and powder. It meant laying off 300 workers and taking a $100 million hit for the restructuring.

Lincoln's loss was Switzerland's gain. The company reversed course on its planned closure of an OTC plant in Prangins. It is now making an immediate investment of €60 million ($78.6 million) to modernize the plant and expand it. Novartis intends to invest another €90 million ($118 million) by 2020, with plans to boost its capacity by 70% in the next 10 years to feed its growing emphasis on OTC products.

- here's the FDA report

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Novartis remediation drags on longer than expected
FDA report shows deep problems at closed Novartis Consumer Health plant
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