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Novartis recalls US products

The consumer health unit of Swiss drug maker Novartis has decided to voluntarily recall four over-the-counter products in the United States.

This content was published on January 9, 2012 - 11:34
swissinfo.ch and agencies

The company said in a statement on Sunday that operations and shipments had been temporarily stopped at the Novartis Consumer Health (NCH) facility in Lincoln, Nebraska, to accelerate improvements at the site. It expects to take a $120 million (SFr114.3 million) charge in the fourth quarter.

The group is recalling Excedrin and NoDoz products with expiry dates of December 20, 2014, or earlier as well as Bufferin and Gas-X Prevention products with expiry dates of December 20, 2013, or earlier, in the US.

The products are being recalled due to an internal product review and complaints that identified issues such as broken gel caps, chipped tablets and inconsistent bottle-packaging line-clearance practices, where a potential for a tablet mix up could not be ruled out.

Novartis pointed out that chipped tablets or mixing different products in the same bottle could result in users taking the incorrect product and either receiving a higher or lower dosage than intended or an unwanted compound.

Novartis said there had not been any adverse events reported and that the US Food and Drug Administration (FDA) was aware of the recall.

The company plans to resume operations gradually at its Lincoln site following implementation of planned improvements and in agreement with the FDA.

The Lincoln facility produces a variety of products mainly for the market with annual sales value of less than two per cent of Novartis Group sales, Novartis said.

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