FDA: Novartis pill mix-up may involve prescription painkillers

Wikimedia Commons
Wikimedia Commons

(CBS/AP) The Food and Drug Administration and Swiss drug maker Novartis warned yesterday that over-the-counter medications may be mixed up with powerful painkillers.

Officials advised consumers to stop using the products following hundreds of complaints about broken or incorrect tablets winding up in pill bottles.

Novartis recalled 1,645 lots of drugs including Excedrin, Bufferin, NoDoz and Gas-X. These drugs may have accidentally been packaged at the Lincoln, Neb., facility 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.

The painkillers are not being recalled because FDA officials say 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.

During an inspection, 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, Cox said. The agency says the investigation is ongoing and would not comment on potential penalties against Endo or Novartis.

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.

"FDA is working with Endo and Novartis to minimize the degree of impact. The degree of shortage will depend upon how quickly safeguards can be put in place to prevent this manufacturing issue from happening in the future," the FDA said in a statement on its website. Regulators are concerned about a possible shortage of Endo's painkillers due to the shutdown of the Nebraska facility.

Novartis 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.

Consumers should visit for a full list of recalled products, and they can call Novartis at 1-888-477-2403, Monday through Friday, 9 a.m. to 8 p.m. EST. Patients can also call Endo Pharmaceuticals' call center at 1-800-462-3636.