Novartis’ Nebraska OTC plant still troubles company
pharmafile | February 11, 2013 | News story | Manufacturing and Production |Â Â Novartis, OTCÂ
Novartis has been forced to recall various over-the-counter (OTC) medicines made at its plant in Lincoln, Nebraska, after discovering failures in child-resistant bottle closures.
The recall relates to products made at the facility before it was closed down voluntarily in December 2011 because of Good Manufacturing Practice (GMP) violations, a shutdown which resulted in significant supply shortages for some of the company’s biggest-selling OTC medicines, including items in its Excedrin painkiller range.
The Lincoln plant re-opened last May but progress with remediation has been slower than hoped, with Novartis forced to turn to third-party manufacturers and co-packagers to restore product supplies.
The products affected by the latest recall are 183 lots of Triaminic Syrups and Theraflu Warming Relief Syrups distributed in the US, said the company.
“The child-resistant feature of the bottle cap may not function properly, enabling the cap to be removed with the tamper-evident seal still in place,” said Novartis in a statement, adding that it had received four notices of adverse events related to the products, with one incident involving a child who was hospitalised but discharged unharmed.
In the latter half of 2012 Novartis was able to re-launch Excedrin and other affected brands – including Triaminic and Lamisil AT – but sales at its consumer health division as a whole fell 19% in 2012 to $3.7 billion as a result of the supply disruptions.
Novartis is also being affected by GMP issues at some sterile production units operated by its generics subsidiary Sandoz, but chief executive Joe Jimenez confirmed on the firm’s fourth-quarter results call that one of these plants – Broomfield in Colorado – is now back to full compliance.
The firm was in the throes of a major restructuring of its manufacturing during 2012, divesting seven plants during the course of the year and bringing the total number sold off to 15 since 2010, whilst also upgrading quality systems across its network.
Phil Taylor
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