The QMN Weekly Bulletin
Pharmaceuticals / Regulatory Affairs / GMPs

Massive Novartis OTC Drug Recall Obscures Manufacturing Improvements

Feb. 7, 2014

Novartis is recalling more than 200 lots of OTC cold and flu drugs distributed in seven countries — a massive market correction by the company beset with quality problems at its OTC plants since 2012.

The recall covers more than a dozen formulations of Novartis’ Theraflu product, also marketed as NeoCitran, that are potentially contaminated with foreign particles, the FDA said Thursday. It involves tens of millions of individual cartons of the products, which were produced at Novartis’ troubled Lincoln, Neb., facility. The Lincoln plant was temporarily shuttered in 2012 to address possible commingling of OTC products and prescription opioids.

Novartis has hired quality consultants and investigators to review and close out hundreds of complaint investigations since Oct. 15, 2012, and the plant is on the mend. It recently received a positive audit by FDA investigators, Novartis CEO Joseph Jimenez said on an investors call Jan. 29. The drugmaker expects to be in a position to ship Theraflu in time for the 2014-15 cold and flu season, according to Brian McNamara, head of the company’s OTC division.

In addition to improvement at Lincoln, Sandoz manufacturing facilities at Broomfield, Colo. and Boucherville, Quebec, are now FDA-compliant following recent inspections there, Jimenez said. The company is still waiting to get feedback from the agency on Sandoz’s Wilson, N.C., plant.

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