Possible Drug Mix-up
January 9, 2012
By Madison Park
Machinery problems at a drug manufacturing plant prompted the U.S. Food and Drug Administration to warn patients of a possible mix-up affecting various prescription pain medications and over-the-counter drugs.
The FDA is advising patients who use certain prescription medications produced by Endo Pharmaceuticals to visually inspect their pills. And consumers who have select bottles of Excedrin, Bufferin, NoDoz and Gas-X, produced by Novartis, are being told to discard or return the products in a voluntary recall that started Sunday.
The over-the-counter drugs involved in the recall were manufactured at a Lincoln, Nebraska, facility which also produced various prescription pain medicines for Endo Pharmaceuticals, according to the U.S. Food and Drug Administration. These pills include Percocet, Opana and Percodan.
“Due to problems that occurred when these products were packaged and labeled at the site, it’s possible that tablets from one product may have been retained in the packaging machinery and then may have carried over into the packaging of another product,” said Dr. Edward Cox, director of the Office of Antimicrobial Products, Office of New Drugs, Center for Drug Evaluation of Research for the FDA.
“This could result in an incorrect pill ending up in the bottle of another product. The likelihood of this occurring in medication dispensed in patients is estimated to be low,” he added.
The prescription opioids could have ended up in the bottle of another prescription drug or over-the-counter products, although “the risk of pills ending up in the wrong bottle is a rare event,” according to the FDA.
There have been no reports of adverse events due to this problem, Cox said.