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BASEL, Switzerland — Novartis Consumer Health Inc. is voluntarily recalling certain over-the-counter medicines in the United States, including pain reliever, alertness aid and anti-gas brands.
The company said late Sunday that the recall encompasses all lots of select bottle packaging configurations from retailers of Excedrin and NoDoz products with expiration dates of Dec. 20, 2014. or earlier as well as Bufferin and Gas-X Prevention®. products with expirations of Dec. 20, 2013 or earlier, all in the United States.
Novartis stated that it’s taking this action as a precautionary measure, saying that "the products may contain stray tablets, capsules, or caplets from other Novartis products, or contain broken or chipped tablets." The company said that there have been no reports of adverse events in connection with the affected products. as a result of these issues.
Information on the recalled bottle sizes and related expiry dates are available at novartisOTC.com.
The drug maker noted that the recall follows the recent, voluntary suspension of operations and shipments from its Lincoln, Neb., facility and that the actions were taken to accelerate maintenance and other improvement activities at the site.
"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," Novartis chief executive officer Joseph Jimenez said in a statement. "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 explained that it’s recalling the products because of an internal product review and complaints that identified issues such as broken gelcaps, chipped tablets and inconsistent bottle packaging line clearance practices, in which "the potential of a tablet mixup could not be ruled out."
The company said it aims to gradually resume operations at its Lincoln site after the implementation of planned improvements and in agreement with the Food and Drug Administration. The facility makes a variety of products, mainly for the U.S. market, with annual sales value of less than 2% of Novartis Group sales.
