Novartis Must Close Plant as FDA Reviews Possible Opioid, OTC Mix-Up

Novartis had to temporarily shutter its Lincoln, Neb., OTC drug plant after being hit with a 13-page Form 483 noting “a pattern of problems” with investigations into foreign tablets that appeared in product batches.

The FDA inspection uncovered packaging machinery that may have retained OTC drug tablets and mixed them with opioid tablets that Novartis manufactures under contract for Endo Pharmaceuticals. Agency field investigators found the company hadn’t heeded consumer complaints and “consistently” had not followed deviation investigations.

Novartis expects to take a $120 million financial hit in its fourth quarter for remediation costs at the plant.

How safe are your outsourced products? In some cases, just one stray tablet is all it may take to adulterate — and ruin — costly batches of your products. And if you’re like many drugmakers, you’re worried.

Indeed, a recent survey found the number one concern drugmakers have as they evaluate a potential contract manufacturing organization (CMO) is this: Does the CMO have the prevention and handling capabilities to ensure cross-contamination and can it manage them well enough?

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