WASHINGTON – The Food and Drug Administration is warning patients about a potential mix-up between powerful prescription pain drugs and common over-the-counter medications made at a Novartis manufacturing plant.
The issue stems from manufacturing problems at a Lincoln, Neb., facility which triggered a recall Sunday of 1,645 lots of Novartis’ over-the-counter drugs, including Excedrin, Bufferin, NoDoz and Gas-X. The company has received hundreds of complaints of broken and chipped pills and inconsistent bottle packaging that could cause pills to be mixed up. Consumers are advised to stop using the products and contact the company for a refund.
FDA officials warned Monday that some of Novartis’ over-the-counter pills may have accidentally been packaged with powerful prescription painkillers made at the same facility. The opioid drugs are sold by Endo Pharmaceuticals as Percocet, Endocet, Opana and Zydone.
Endo Pharmaceuticals Holdings Inc., of Chadds Ford, Pa., said it is not aware of any confirmed product mix-ups that reached patients or caused any injuries. A spokeswoman for Novartis said late Monday that only Gas-X is produced on the same manufacturing line as the opioid drugs.
FDA officials say they are not recalling the painkillers because they are essential medications for many patients and the risks of stray pills are low.
The FDA and Endo Pharmaceuticals recommend patients examine their prescriptions to make sure all the tablets are similar in shape, color, size and marking. If one or more of the tablets look different, patients should return the medicine to their pharmacist. Patients can call Endo Pharmaceuticals’ call center at (800) 462-3636.
Novartis AG announced Sunday it would recall certain bottles of headache medicine Excedrin and caffeine caplets NoDoz with expiration dates of Dec. 20, 2014. The company is also recalling some packages of pain medicine Bufferin and stomach medicine Gas-X with expiration dates of Dec. 20, 2013, or earlier.
Customers can also call the company at (888) 477-2403.