Broken Tablets, Possible Mix-Ups in Packaging Lead Novartis to Recall Certain OTC Drugs

Packaging inconsistencies as well as broken or chipped tablets have prompted Novartis Consumer Health Inc. (NCH) to conduct a sweeping recall. NCH is voluntarily recalling 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, the company reported on its Web site. These products "may contain stray tablets, capsules, or caplets from other Novartis products," it reported.

While consumers did complain of chipped and broken pills, NCH is not aware of adverse events related to the issues leading to the recall.

Just before the recall, NCH ceased operations at and shipments from its Lincoln, NE facility. "These actions were taken to accelerate maintenance and other improvement activities at the site," the company reported on its site. It plans to "gradually resume operations at its Lincoln, NE site following implementation of planned improvements and in agreement with the FDA."

"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," said Joseph Jimenez, CEO of Novartis, on the company's Web site. "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."

FDA also posted the press release to its site. For a list of affected products, see this list of Excedrin, Gas-X, and more.

The Associated Press is reporting that FDA is warning that these OTC products may have been mixed up with "Percocet, Endocet, Opana, and Zydone." Read this story on possible opioid mix-ups.