Novartis Recalls OTC Products Excedrin And NoDoz

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Main Category: Pharma Industry / Biotech Industry
Also Included In: Pharmacy / Pharmacist
Article Date: 09 Jan 2012 - 9:00 PST

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Complaints of chipped and broken pills as well as inconsistent packaging have promoted Novartis Consumer Health Inc. (NCH) to recall certain lots of its products.

Whilst there have been no reports of adverse effects to patients so far, Novartis has also warned of possible mixing of product. They have asked consumers to dispose of the product or return unused bottles. They have also temporarily suspended operations in their Lincoln, Nebraska production facility.

All lots of select bottle packaging configurations from retailers of 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 United States are to be considered suspect, and Novatris says :

"[It] is taking this action as a precautionary measure, because the products may contain stray tablets, capsules, or caplets from other Novartis products, or contain broken or chipped tablets."

However, consumers should be aware that mixing of the product may result in patients taking the incorrect medication, and doses cannot be assured where pills are chipped or broken. The recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA). Novartis Consumer Health has provided its assurance that it will continue to work closely with the Agency as well as its customers throughout this process.

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 ... The high quality of our products and operations has been critical to building the Novartis reputation over the past 15 years. We are committed to ensuring the highest standard for patients who rely on our products and medicines."

Novartis says it plans to gradually resume operations at its Lincoln, NE site following implementation of planned improvements and in consultation with the FDA. This facility produces a variety of products mainly for the US market, but constitutes less than 2% of Novartis Group sales. The company says at this stage, it is not possible to determine when the plant will resume full operations and the full financial impact of these events. The cost of the recall is estimated at some 120 Million USD, and Novartis says it will take a one time write down in its fourth quarter 2011, whilst taking action to improve production quality.

Consumers and customers in the US who have questions can call the Consumer Relationship Center at 1-888-477-2403 (available Monday-Friday 9 a.m. to 8 p.m. Eastern Time).

For more detailed information regarding the product, potential drug reactions, impacted configurations, related NDC numbers and expiry dates, consumers can visit the Novartis website starting January 9, 2012 at www.novartisOTC.com

A form is available online to apply for a refund for any faulty product.

Written by Rupert Shepherd


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