Novartis Consumer Health Inc. (NCH) has recalled several over-the-counter products in the U.S., suspended operations at its Lincoln, NE facility, and taken a $120 million charge due to quality issues.

NCH began a voluntary recall in the U.S. of certain configurations of Excedrin and NoDoz products, as well as Bufferin and Gas-X Prevention. In a press statement, the company said the recall is “a precautionary measure, because the products may contain stray tablets, capsules, or caplets from other Novartis products, or contain broken or chipped tablets.” The shutdown of Lincoln began on December 19 and was taken “to accelerate maintenance and other improvement activities at the site.”

The company plans to resume operations at Lincoln in stages, with FDA approval, but would not estimate when the plant will resume full operations. As first reported by Pharmalot on January 6, Novartis received a 483 from the FDA last July (PDF here)citing a litany of quality problems at the site, including numerous failures to investigate consumer claims of mixed products.

As a result of the Lincoln shutdown, Endo Pharmaceuticals announced that it may suffer shortages of several analgesic products made there. Endo has begun manufacturing Percocet and Endocet at its own facility in Hunstville, AL, but Novartis is the sole manufacturer of the Endo’s Opana ER product. Julie McHugh, Endo’s chief operating officer, remarked, “We plan to temporarily moderate demand of [Opana ER] by asking physicians to refrain from starting new patients on it in order to minimize disruption for patients currently on the product. We currently expect this to be a short-term issue and we remain focused on working with the healthcare community to optimize the continued supply of our products for current patients.”

Novartis also received warning letters for three of the North American facilities for its Sandoz unit last November. No plant shutdowns have been announced in relation to those inspections.

Joseph Jimenez, chief executive officer of Novartis, commented, “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. 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.”