Novartis Issues Recall and Suspends Operations at US Facility

Novartis Consumer Health has announced a voluntary recall of all lots of select, bottle-packaged configurations of Excedrin, NoDoz, Bufferin, and Gas-X Prevention. According to a media release, the recall follows consumer complaints of chipped or broken pills and inconsistent bottle packaging line clearance practices that could lead to stray tablets, capsules, or caplets from other Novartis products. US consumers have been advised to either destroy or return unused product identified in the recall. No related adverse events have been reported.

Operations at the Lincoln, Nebraska, facility have been temporarily suspended to facilitate necessary planned improvements, with production gradually resuming in agreement with FDA. However, a timescale for a return to full operational capacity has not been established. Shipments from the site have also been halted.

Joseph Jimenez, CEO of Novartis, said in the press release, “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.”

In a separate press release, FDA subsequently issued a public health advisory notice indicating the potential safety risk of stray tablets in Endo Pharmaceuticals opiate products, which are also manufactured and packaged by Novartis at its Nebraska facility. FDA has advised patients and healthcare professionals to examine Endo opiate medicines in their possession to ensure that all tablets are identical.

Endo Pharmaceuticals announced a potential supply-chain disruption following the Nebraska site shutdown. “We are working collaboratively with the FDA to minimize the disruption to patients currently on therapy. Given existing inventories, the expected restart of Novartis production, and our ability to shift production to other facilities we believe the supply constraints of our products should be limited,” said Julie McHugh, chief operating officer of Endo Pharmaceuticals in a press statement. “With Novartis as the sole manufacturer of the current formulation of Opana ER, we plan to temporarily moderate demand of the product by asking physicians to refrain from starting new patients on Opana ER in order to minimize disruption for patients currently on the product.”