Novartis adds OTC drug plant to GMP fix list

Popular OTC drugs Excedrin, Theraflu, Triaminic and Maalox may become harder to find in the coming months, thanks to a voluntary manufacturing halt by Novartis ($NVS). The Lincoln, NE, plant shutdown comes on the  heels of an unrelated warning letter to CEO Joe Jimenez (photo) concerning GMP violations at three North American facilities of its generics unit, Sandoz.

The Lincoln shutdown will allow for "compliance improvement activities," reports Ed Silverman in Pharmalot, citing a company spokesperson. The activities will "expedite maintenance and improvements and continue to strengthen standards."

The action suggests Novartis is undertaking "an even broader compliance overhaul" than that required by the three-plant Sandoz warning, Silverman speculates. The Novartis spokesperson didn't reveal whether a regulatory inspection preceded the Lincoln plant shutdown.

In the November Sandoz warning letter to Jimenez, the FDA was particularly pointed in detailing agency expectations for the involvement of high-level leadership in GMP-violation responses. "Corporate management has the responsibility to ensure the quality, safety, and integrity of its products. Neither upper management at Novartis nor at Sandoz ... ensured global, adequate, or timely resolution of the issues," the letter stated.

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