Painkiller recall after possible pill mix-up

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 that triggered a voluntary 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 yesterday that some of Novartis' over-the-counter pills may have accidentally been packaged with powerful prescription painkillers made at the facility. The opioid drugs are sold by Endo Pharmaceuticals as Percocet, Endocet, Opana and Zydone.

Endo said it is not aware of any confirmed product mix-ups that reached patients or caused any injuries. A spokeswoman for Novartis said late yesterday 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 likelihood of finding a wrong tablet in an opiate pain medication dispensed to patients is low and patients should not be unduly alarmed," FDA's Dr. Edward Cox told reporters.

Cox said FDA inspectors uncovered a manufacturing problem that could allow pills to become stuck in the machinery and carry over to the packaging of other products.

Customers can call Endo Pharmaceuticals at 800-462-3636 and Novartis at 888-477-2403.