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FDA advises of pain medicine mix-up

January 11, 2012

By Kelly Soderlund

The U.S. Food and Drug Administration wants health professionals to be aware of a packaging problem at a Nebraska pharmaceutical plant where there were three instances of opiates being mixed in with over-the-counter pain medications.

Dentists who prescribe pain medication should advise their patients of the situation and be sure to check their own supply of medicine to be sure all of the pills match.

The advisory applies to tablets manufactured for Endo Pharmaceuticals by Novartis Consumer Health. It does not apply to liquid and powder form medicines or blister packaged products manufactured by the same company. The FDA says it's working with Novartis and Endo to resolve the packaging problem.

In a letter, www.endo.com/Supply_disruption.aspx, Endo said there may be a short disruption in the supply and distribution of the medications involved. The letter also said the company is not aware of any patient who experienced a product mix-up or adverse events resulting from a mix-up.

A list of potentially affected medications, including different strengths of Percocet, morphine and Zydone, can be found at www.fda.gov/Drugs/DrugSafety/ucm286232.htm. The FDA is advising consumers and health professionals who think they have any of the medications to inspect all of their tablets.

If one or more of the tablets in the bottle look different or there are tablets that are different shapes, colors or sizes or the markings are different, the FDA's advice is to bring the medicine bottle to the pharmacist and not take any of the tablets.

Health professionals who have products from Endo Pharmaceuticals are instructed to visually inspect and verify the identity of the tablets, including bottles that have never been opened. Endo has provided photographs of the potentially affected products at www.endo.com.