Novartis Recalls Excedrin, Bufferin for Tablet Damage, Suspends Production

Novartis AG (NOVN) said it’s voluntarily recalling some over-the-counter products in the U.S., including its Excedrin headache pills and NoDoz medication, because they may contain broken or stray tablets from other products.

Novartis has temporarily suspended operations at the Lincoln, Nebraska, plant where the products were made, the company said in a statement today. The recall also affects its Bufferin and Gas-X Prevention brands.

The move comes after consumer complaints “of chipped and broken pills and inconsistent bottle packaging line clearance practices possibly resulting in mixed tablets,” the company said in the statement. The over-the-counter medications were distributed throughout the U.S.

Julie Masow, a spokeswoman for the Basel, Switzerland-based company, said she didn’t immediately have a number for the amount of tablets and gel caps involved in the recall. She said there hadn’t been any reports of overdoses or allergic reactions from the stray material or broken and chipped medication. The Lincoln facility has 620 employees and about 200 temporary workers, Masow said.

Novartis said the recall and improvement work at the Lincoln plant will result in a fourth-quarter charge of $120 million before tax. The facility’s products account for less than 2 percent of Novartis Group sales, the company said. The drugmaker had sales of $50.6 billion in 2010.

Novartis said the recall is being done with the knowledge of the U.S. Food and Drug Administration.

Novartis said it was recalling all lots of bottles containing Excedrin and NoDoz with expiration dates of Dec. 20, 2014, or earlier as well as Bufferin and Gas-X Prevention with throw-out dates of Dec. 20, 2013 or sooner.

To contact the reporter on this story: Dan Hart in Washington at dahart@bloomberg.net

To contact the editor responsible for this story: Sylvia Wier at swier@bloomberg.net

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