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FDA Warns of Painkiller Mix-Up at Nebraska Plant
Date:1/9/2012

By Steven Reinberg
HealthDay Reporter

MONDAY, Jan. 9 (HealthDay News) -- The U.S. Food and Drug Administration issued a warning on Monday that some narcotic prescription painkillers made at a Nebraska plant may have been mixed up with some over-the-counter medicines packaged at the same facility.

"We issued a public health advisory to health care professionals and patients about a potential problem with opioid products manufactured and packaged for Endo Pharmaceuticals by Novartis Consumer Health at its Lincoln, Nebraska, site," Dr. Edward Cox, director of the FDA's Office of Antiviral Products in the Office of New Drugs at the Center for Drug Evaluation and Research, said during a morning news conference.

On Sunday, Novartis issued a recall for some over-the-counter medications made at the same plant. These included Excedrin, NoDoz, Bufferin and Gas-X, Cox said.

"Mixing of different products in the same bottle could result in consumers taking the incorrect product and receiving a higher or lower strength than intended, or receiving an unintended ingredient," Novartis said in the Sunday news release. "This could potentially result in overdose, interaction with other medications a consumer may be taking, or an allergic reaction if the consumer is allergic to the unintended ingredient."

Cox noted that it is possible, but unlikely, that these over-the-counter medications and prescription opioid painkillers could be mixed up together, although "we are still looking into this."

The narcotic painkillers in question include Opana, Percocet, Endocet and Zydone.

The problem occurred because the machinery used to package these products can retain pills from a previous packaging run, Cox explained.

"This could result in an incorrect pill ending up in the bottle of another product," Cox explained. "The likelihood of this occurring in medication dispensed to patients is estimated to be low."

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