Possible Insertion of Narcotics into Bottles Leads to Drug Recall

On behalf of Brown & Crouppen, P.C. posted in Defective Medications on Monday, January 30, 2012

A problem at a pharmaceutical plant that produces over-the-counter medicine for Novartis led to a recall of hundreds of lots of four of the drug maker’s products earlier this month. The problem in the production line may have led to doses of powerful narcotics being inserted into the over-the-counter drugs’ bottles by mistake. Inadvertent ingestion of the more powerful drugs, which include opioids like Percocet, could have serious side effects for users.

According to the Food and Drug Administration, agency inspectors visiting a pharmaceutical plant that produces Novartis products like Excedrin, Bufferin, NoDoz and Gas-X, as well as opioid painkillers for Endo Pharmaceuticals. The inspectors found a problem with the manufacturing equipment that could allow pills to get put into the wrong bottles. Novartis and the FDA announced the recall soon after.

The company recalled 1,645 lots of the four medicines, though a spokeswoman said that Gas-X is the only product made on the same line as the more powerful drugs. The FDA and Endo did not order a recall of the opioids, which include Percocet, Endocet, Opana and Zydone because a shortage of those drugs could be a serious problem for patients and the likelihood of a pill winding up in the wrong bottle was relatively low.

Users of any of the drugs mentioned above are encouraged to inspect their bottles to make sure all the pills are the same size, shape, color and marking. If any of the pills appear different, patients should return the bottle to the pharmacy.

Source: CBS News, “FDA: Novartis pill mix-up may involve prescription painkillers,” Monica DyBuncio, Jan. 10, 2012

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