Novartis recalls products as GMP issues close OTC facility
pharmafile | January 9, 2012 | News story | Manufacturing and Production |Â Â FDA, Novartis, OTCÂ
Novartis has revealed that it is temporarily shutting down a manufacturing facility in Nebraska, US, and recalling four products as it tries to address good manufacturing practice (GMP) violations.
The news comes after Novartis was sent a warning letter for three of other manufacturing facilities – two in the US and one in Canada – which also revealed numerous GMP violations during inspections in 2011.
In the latest development, Novartis has suspended production at the over-the-counter (OTC) and veterinary medicines-producing plant in Lincoln, Nebraska, in order to focus on bringing the unit back into compliance.
It has also issued a recall notice for the painkiller Excedrin, NoDoz caffeine tablets, aspirin product Bufferin and dietary supplement Gas-X Prevention, because “the products may contain stray tablets, capsules, or caplets from other Novartis products, or contain broken or chipped tablets”, said the firm in a statement.
Other OTC medicines made at Lincoln include the cold and flu remedies Theraflu and Triaminic, heartburn treatment Maalox, antifungal Lamisil (terbinafine) and fibre supplement Benefiber, according to Novartis, which has said supplies of the drugs may be disrupted as a result of the shutdown.
The company expects to take a $120 million charge in its fourth quarter financial results as a result of the recalls and remediation efforts at the Lincoln plant.
According to the FDA’s website, the agency issued a Form 483 report on the facility after an inspection in August 2011 which revealed a number of GMP violations, including deficiencies in the operations of its quality control unit.
It appears the inspection was prompted by a series of complaints about products manufactured at the facility, with 40 samples returned by customers which were not properly investigated.
The company also failed to look into 166 complains of foreign tablets in drug products made at Lincoln since 2009, says the report, and did not include all batches affected by a quality control issue in its investigations, a failing which had been picked up in an earlier inspection report.
Furthermore, the QC unit did not provide timely notification to the agency of QC failures or customer complaints, or indeed pass information on issues up the chain of command within the company, with the behaviours “indicative of a pattern of problem at your firm”.
In fact, the Form 483 makes a number of statements alluding to ‘patterns’ or ‘consistent’ failings which suggests the FDA is worried that the plant has systemic manufacturing and QC issues to tackle.
Novartis said it will have a clearer idea when production will be able to resume later this year, but in the meantime is co-operating with the FDA in efforts to bring the facility back on track. Products made at Lincoln account for less than 2% of total group sales, it added.
Phil Taylor
Related Content
MRM Health’s ulcerative colitis treatment receives FDA Investigational New Drug clearance
Microbial Resource Management (MRM) Health has announced that its lead programme, MH002, has received Investigational …
Complement Therapeutics’ geographic atrophy treatment receives FDA Fast Track designation
Complement Therapeutics has announced that CTx001, its gene therapy treatment for geographic atrophy (GA) secondary …
Johnson & Johnson submits robotic surgical system for De Novo classification
Johnson & Johnson has announced the submission of its Ottava Robotic Surgical System for De …
