Opioids involved in drug mix-up at Novartis facility

The FDA is warning that pills, tablets or caplets of Percocet and eight other opioids manufactured by Novartis and Endo Pharmaceuticals may have been mixed-up, with one packaged as another, due to problems at a Lincoln, Neb., plant.

The opioids involved include Opana ER CII, Opana CII, Percodan CII, Oxymorphone hydrochloride CII, Endocet CII, Endodan CII, Morphine sulfate ER CII and Zydone CIII.

Pharmacists should visually inspect all potentially affected opioid drugs to prevent the spread of improperly packaged medications, Edward Cox, MD, director of the FDA's Office of Antiviral Product, Office of New Drugs, and the Center for Drug Evaluation of Research, advised during a press conference.

Patients should also be on the lookout for pills that are different in size, shape, color or markings from their standard medication or are different from others in the container. A complete list of medication strengths, as well as a visual guide is available on the Endo website.

The Novartis facility is the same involved in a recall of OTC medications, including Excedrin and NoDoz. The FDA was unable to determine whether the opioids may have cross-contaminated the OTC medications, Cox said.

Although the FDA considered issuing a recall for the affected opioids, the agency decided against it after concluding that the odds for adverse events from the mix-up are low, whereas demand for the medications are high, and potential exists for product shortages to occur while the facility is shut down and inspected.

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