PARSIPPANY, N.J. -- Novartis Consumer Health Inc. (NCH) is voluntarily recalling all lots of select bottle packaging configurations of Excedrin and NoDoz products with expiration dates of December 20, 2014, or earlier as well as Bufferin and Gas-X Prevention products with expiration dates of December 20, 2013, or earlier, in the United States. 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 NCH Lincoln, Neb., facility has voluntarily suspended operations and shipments to accelerate maintenance and other improvement activities at the site.
This recall is being conducted with the knowledge of the U.S. Food & Drug Administration (FDA).
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, it said.
These over-the-counter 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.
Consumers that have any of the products being recalled should stop using them and contact NCH to receive a full refund. 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.
NCH said it plans to gradually resume operations at its Lincoln site following implementation of planned improvements and in agreement with the FDA. 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 $120 million in the fourth quarter of 2011 relating to the recalls and improvement work at the Lincoln facility, it said.
The Novartis Group is based in Basel, Switzerland.
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