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Entries in Bufferin (2)

Monday
Jan092012

Excedrin, NoDoz, Bufferin Recalled

Hemera/Thinkstock(WASHINGTON) -- Packaging problems at a drug manufacturing plant may have resulted in powerful prescription painkillers ending up in packages of Excedrin, NoDoz, Bufferin and Gas-X Prevention.

Novartis announced a recall of the over-the-counter products on Sunday, citing customer complaints about chipped and broken pills. That notice did not mention any concern that prescription painkillers might have been mixed into bottles of over-the-counter drugs.

But at a news conference Monday, a senior FDA official told reporters, “There is the potential risk that could happen.”

The concern was prompted by an FDA inspection last month of a plant in Lincoln, Neb., operated by Endo Pharmaceuticals, which produces drugs for Novartis Consumer Health. That inspection turned up evidence of three product mix-ups since 2009.

The FDA on Monday warned doctors, pharmacists and patients that certain prescription painkillers made by Novartis may have mistakenly ended up in bottles of other prescription painkillers or with over-the-counter products packaged on the same lines.

Dr. Edward Cox, a director at the FDA’s Center for Drug Evaluation and Research, said the agency has received some complaints but has no reports of people getting sick from Novartis products.

“We think the risk of this product mix-up occurring is low,” Cox said.

Copyright 2012 ABC News Radio

Monday
Jan092012

Novartis Recalls Excedrin, Bufferin, NoDoz and Gas-X as Precaution

Michele Tantussi/Bloomberg via Getty Images(PARSIPPANY, N.J.) -- Novartis Consumer Health Inc., one of the world’s largest drug companies, announced on Sunday that it is voluntarily recalling several over-the-counter products after complaints of chipped and broken pills and inconsistent bottle packaging.

The Switzerland-based company described the move as a precaution to strengthen its standards, and said these issues have led to no adverse events.

The drugs being recalled are the pain reliever Excedrin and the caffeine tablets NoDoz with expiration dates of Dec. 20, 2014 or earlier, and the aspirin Bufferin and stomach medicine Gas-X Prevention with expiration dates of Dec. 20, 2013 or earlier.  The drugmaker says these bottles may contain pills of other Novartis products, or pills that are chipped and broken.

[CLICK HERE TO SEE THE FULL LIST OF IMPACTED PRODUCTS]

Novartis has suspended operations and shipments from its factory in Lincoln, Neb.  The company said it plans to work with the Food and Drug Administration to make improvements before resuming operations.

Copyright 2012 ABC News Radio







ABC News Radio