OTC plant bites Novartis' reputation again
|CEO Joe Jimenez|
This time Novartis acknowledged that its poor manufacturing resulted in four children popping off "childproof" caps on cough syrups and taking a drink. Spokeswoman Julie Masow told FiercePharma that one of the children was hospitalized but fully recovered.
More than a year after Novartis closed the plant to address the substantial shortcomings FDA inspectors found there, it is recalling 183 lots of cough and cold products during the worst flu season in the U.S. in several years. Masow said that because the products were manufactured before December 2011, about 97% is believed to have been used or returned. "It is unlikely much of it remains on shelves or in consumers' homes," Masow said. The products themselves are safe and the recall is "voluntary and precautionary," she said.
The plant problems have plagued the company since FDA inspectors found pages of shortcomings during inspections and Novartis voluntarily closed it in December 2011. The expense of fixes and the lost revenue from limited lines of over-the-counter (OTC) products for sale has been a drag on Novartis' earnings. In the third quarter, OTC sales were off 22% to $938 million. Delays required Jimenez to eat his words about when the plant would reopen and finally just say he no longer would make predictions. Questions raised by the plant problems and others in the Swiss company's manufacturing also led him to launch a program for employees to focus on quality.
The company had actually started ramping up production of some products, like Excedrin Migraine, in the fall and returning them to retailers. A consumer complaint about the cough products in late November triggered an internal investigation, which led Novartis Consumer Health to bite the bullet and recall whatever of the products might still be unused.
- here's the release
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