Novartis Recalls OTC Drugs That May Contain Other Drugs
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.
The recalled products may contain stray tablets, capsules, or caplets from other Novartis products, or contain broken or chipped tablets. These over-the-counter products were distributed nationwide to wholesalers and retailers. Click the link for a complete list of products.
Different products mixed 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.
The NCH facility in Lincoln, NE has voluntarily suspended operations and shipments to accelerate maintenance and other improvement activities at the site. The company 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.
NCH plans to gradually resume operations at its Lincoln, NE site following implementation of planned improvements and in agreement with the FDA. The facility produces a variety of products mainly for the US market with annual sales value of less than 2% 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 USD 120 million in the fourth quarter of 2011, relating to the recalls and improvement work at the Lincoln, NE facility.
If you have legal questions about an illness, hospitalization or medical event that may be associated with this recall, contact the attorneys at PritzkerOlsem P.A. for a free consultation.
