Novartis pulls OTC meds made at troubled plant

On the heels of a temporary plant shutdown last month, Novartis ($NVS) has recalled four over-the-counter drugs made there. It's a precautionary recall, the company's consumer health division reports, affecting Excedrin, NoDoz, Bufferin and Gas-X Prevention products. For readers of an FDA inspection report, the reason for the recall isn't much of a surprise: Product packages might contain other Novartis pills gone astray, or chipped or broken tablets, the company says.

Novartis temporarily halted production at the Lincoln, NE, plant where these drugs were made, saying that the facility was due for maintenance and improvements. At the time, the company warned that its consumer-drug supplies, as well as some veterinary products made there, could run short while the plant is on idle. Besides the four recalled products, the Lincoln plant turns out the cold and flu drugs Theraflu and Triaminic, the antifungal Lamisil, the stomach drug Maalox, and the dietary supplement Benefiber.

The Novartis recall follows a number of yanked products over the past year or so, with the highly publicized Johnson & Johnson ($JNJ) consumer drug recalls only the most obvious example. Other mislabeled and mispackaged drugs have been pulled, along with contaminated injectable meds, oversized prescription pills, and more.

Like J&J, which shuttered a Pennsylvania plant for revamping, Novartis will keep the Lincoln plant closed as improvements are made. In a statement, the company said it's not sure when the plant will be back up to speed, but it will gradually resume operations there as the overhaul proceeds. CEO Joe Jimenez said the company is "making the necessary investments and committing the right resources" to make sure "a single quality standard" is implemented across its entire manufacturing network.

The recall and plant modifications will cause a $120 million charge against fourth-quarter results, the company says. The number of packages affected isn't available, a spokeswoman told Bloomberg. The facility's products account for a small fraction of Novartis sales, the drugmaker noted: less than 2%. Novartis says it's not aware of any adverse events related to the recall.

- see the statement from Novartis
- read the InPharm story
- get more from Bloomberg

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