FDA warns about painkiller mix-up in Excedrin, Bufferin

The Food and Drug Administration is warning patients about a potential mix-up between powerful prescription pain drugs and common over-the-counter medications like Excedrin and Gas-X made at a Novartis manufacturing plant.

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The problem is a result of major manufacturing problems at a Lincoln, Nebraska, facility which was shut down last month. The Swiss drugmaker has recalled bottles of Excedrin, Bufferin and other medications which may have included mixed up pills.

Now the FDA says some of those over-the-counter pills may have accidentally been packaged with powerful prescription painkillers made at the same facility. The opioid drugs are sold by Endo Pharmaceuticals as Percocet, Endocet, Opana and Zydone.

FDA officials say they are not recalling the drugs because they are medically necessary and the likelihood that they contain stray pills is low.

On Sunday Novartis AG issued a nationwide voluntary recall of certain bottled versions of Excedrin and Bufferin, and two other products, saying they may contain stray, broken or chipped tablets from other Novartis products.

Novartis Consumer Health said the recall, which also applies to bottled versions of NoDoz and Gas-X Prevention, is a precautionary measure.

Novartis said mixing of different products in the same bottle could result in taking an incorrect product or receiving a higher or lower strength than intended or receiving an unintended ingredient, which could potentially result in overdose or an allergic reaction.

The recall is for bottled packages of Excedrin and NoDoz with expiration dates of Dec. 20, 2014, or earlier, and for Bufferin and Gas-X Prevention products with expiration dates of Dec. 20, 2013, or earlier.

The company said it has notified its distributors and retailers. Consumers can find more information on the website www.novartisOTC.com as of Jan 9.