Novartis Consumer Health has announced a voluntary recall of all lots of select, bottle-packaged configurations of Excedrin, NoDoz, Bufferin and Gas-X Prevention.
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.”
The Future of Cleanroom Construction: How Hybrid Solutions are Changing the Game
May 14th 2025Imagine a world where cleanroom facilities—essential for pharmaceutical manufacturing, biotechnology, and high-tech industries—are built with unparalleled speed, precision, and efficiency. That world is here, thanks to the hybrid construction approach. By blending traditional stick-built methods with modular and prefabricated solutions, companies are overcoming the limitations of conventional construction while ensuring compliance with stringent industry regulations. In this interview, we explore how hybrid cleanroom construction is transforming the industry, offering faster project timelines, improved quality control, and significant cost advantages. Join us as we delve into this game-changing approach with industry experts who are leading the charge in revolutionizing cleanroom infrastructure.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.