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Broken products prompt voluntary Novartis recall

Novartis Consumer Health Inc. issues nationwide recall of certain OTC products due to potential presence of foreign tablets or chipped or broken tablets or gelcaps.
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FILED IN:  Trends and Issues  > Regulatory  > FDA
     

Parsippany, NJ-based Novartis Consumer Health, Inc. (NCH) voluntarily recalled all lots of select bottle packaging configurations 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 U.S. The recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

NCH 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. The company’s Lincoln, NE facility has voluntarily suspended operations and shipments to accelerate maintenance and other improvement activities at the site.

Mixing of different products in the same bottle could result in consumers taking the incorrect product and receiving a higher or lower strength than intended or receiving an unintended ingredient. This could potentially result in overdose, interaction with other medications a consumer may be taking, or an allergic reaction if the consumer is allergic to the unintended ingredient. NCH is not aware of adverse events reported with the issues leading to the recall.

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These OTC products were distributed nationwide to wholesalers and retailers. NCH is notifying its distributors and customers and is arranging for return of all recalled products. Wholesalers and retailers should stop distribution and return the affected product using Novartis Product Return information that is being provided to them.

Consumers that have the product(s) being recalled should stop using the product(s) and contact the Novartis Consumer Relationship Center at 1-888-477-2403 (Monday through Friday 9 a.m. to 8 p.m. Eastern time) for information on how to return the affected products and receive a full refund. For more detailed information, consumers can visit the company’s Web site. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.

Adverse events that may be related to the use of these products may be reported to FDA's MedWatch Adverse Event Reporting Program either online, by fax 1-800-FDA-0178, or by mail: MedWatch, FDA, 5600 Fishers Lane, Rockville, MD  20852-9787 (a postage-paid FDA form 3500 is available).

The company says the actions “highlight the strong Novartis commitment to a single quality standard for the Novartis Group. The Novartis Group is making the necessary investments and committing the right resources to ensure these are implemented across the entire Novartis Group network. The high quality of Novartis products and operations has been critical to building the Novartis Group reputation over the past 15 years. Novartis Group is committed to ensuring the highest standard for patients who rely on our products and medicines.

“Novartis Consumer Health Inc. plans to gradually resume operations at its Lincoln, NE site following implementation of planned improvements and in agreement with the FDA. The Novartis Consumer Health Inc. Lincoln, NE facility produces a variety of products mainly for the U.S. market with annual sales value of less than 2 percent of Novartis Group sales. At this stage, it is not possible to determine when the plant will resume full operations and the full financial impact of these events. NCH will take a one-time charge currently estimated at US$120 million in the fourth quarter of 2011, relating to the recalls and improvement work at the Lincoln, NE facility,” said a press release on the matter.


 

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