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 

, 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.”

, 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 

. “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.”

News

Novartis Consumer Health has announced a voluntary recall of all lots of select, bottle-packaged configurations of Excedrin, NoDoz, Bufferin and Gas-X Prevention.