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Novartis recalls drugs in plant mix-up

WASHINGTON - The Food and Drug Administration is warning patients about a potential mix-up of powerful prescription pain drugs and common over-the-counter medications made at a Novartis plant.

The issue stems from manufacturing problems at a Lincoln, Neb., facility that triggered a recall Sunday of 1,645 lots of Novartis’s 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’s over-the-counter pills may have 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 injuries.

A spokeswoman for Novartis said yesterday that only Gas-X is produced on the same manufacturing line as the opioid drugs.

FDA officials said they were 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,’’ the FDA’s Dr. Edward Cox told reporters.

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

FDA officials said the investigation is ongoing and would not comment on potential penalties.

The FDA and Endo Pharmaceuticals recommend that patients examine their prescriptions to make sure all the tablets are similar in shape, color, size, and markings.


If one or more of the tablets look different, patients should return the medicine to the pharmacist.

Patients can call Endo Pharmaceuticals’ call center at 1-800-462-3636.

Cox said regulators are also concerned about a shortage of Endo’s painkillers in coming weeks due to the shutdown of the Nebraska facility.

Novartis voluntarily halted production at the plant on Dec. 19.

FDA inspectors cited Novartis’s plant for a dozen quality-control problems last summer, in a report posted to the agency’s website. Company officials failed to properly investigate 166 complaints of mixed-up pills found in Novartis bottles since 2009, according to inspectors.

Novartis AG said in a statement said that it issued the recall “at the appropriate time . . . as a precautionary measure in the best interest of consumers.’’