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Novartis recalls several OTC products in US

Batches of Excedrin, NoDoz, Bufferin and Gas-X Prevention voluntarily withdrawn and operations suspended at Nebraska manufacturing plant

Novartis has recalled batches of four over-the-counter products in the US following complaints of chipped and broken pills as well as well as inconsistent clearance practices for bottle packaging at a manufacturing plant.

Painkiller Excedrin and caffeine tablet NoDoz, with expiry dates of December 20, 2014, have been withdrawn, along with aspirin Bufferin and Gas-X Prevention products that have expiry dates of December 20, 2013.

Speaking to Bloomberg, Novartis' Julie Masow said the number of products involved in the recall was still unknown.

Operations and shipments at the Novartis Consumer Health's facility in Lincoln, Nebraska, which manufactured the products have also been suspended to 'accelerate maintenance and other improvement activities at the site'.

A potential mix up in tablets due to the plant's unreliable practices "could not be ruled out", the company said.

The recalls and required improvements to its Lincoln facility will cost Novartis $120m, which the company expects to book as a one-off charge in its 2011 fourth quarter figures.

It is not known when the plant will resume full operations, or whether the problems will have any further financial impact on the pharmaceutical company.

Joseph Jimenez, CEO of Novartis, said: "We are committed to a single quality standard for the entire Novartis Group and we are making the necessary investments and committing the right resources to ensure these are implemented across our entire network.”

No related adverse events have been reported as of yet, and Novartis said the recalls were a 'precautionary measure'.

9th January 2012

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