Regulatory Focus™ > News Articles > Manufacturing Mix-ups Affect Novartis, Endo Pharmaceuticals

Manufacturing Mix-ups Affect Novartis, Endo Pharmaceuticals

Posted 10 January 2012 | By Alexander Gaffney, RAC 

Swiss pharmaceutical company Novartis Consumer Health Inc. recalled four products yesterday, citing quality concerns that could expose consumers to "foreign tablets, caplets, or capsules," as well as broken and chipped pills.

The product recall affects four popular Novartis-made drugs: Excedrin, NoDoz, Bufferin and GasX.

The US Food and Drug Administration's (FDA) statement noted that consumers could be exposed to dangerous doses, unintended ingredients, allergic reactions and dangerous drug-drug interactions (DDIs) as a result of the mix-up.

Edward Cox, director of FDA's Office of Antiviral Products said that manufacturing issues had resulted in a situation that "could result in an incorrect pill of one medicine ending up in the bottle of another product."

The Novartis statement noted that the company expects to take a Q4 2011 financial hit of roughly $120 million as a result of the quality problems, and that its Lincoln, NE manufacturing plant responsible for the problems would be brought back online "gradually" after FDA-mandated improvements had been made.

The plant shutdown is also expected to affect Endo Pharmaceuticals Holdings Inc, which manufactures several products at the same Nebraska plant, including Opana ER, Percocet, Percodan and Endocet.

No adverse events from the mix-up have been reported thus far.

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