Claris’ manufacturing practices under FDA scrutiny
The alert centres on the intravenous drugs metronidazole, ciprofloxacin and ondansetron, manufactured by Claris Lifesciences. It markets these products through three of its joint ventures to US-based firms Sagent Pharmaceuticals, Pfizer and West-Ward Pharmaceuticals.
The alert came after the FDA received reports of floating matter in IV bags manufactured by Claris. A Claris customer had noticed white matter in a bag of metronidazole. Subsequent microbiological analysis identified the matter as a Cladosporium mould.
The concern is moulds of this type can cause infections in susceptible patients, such as immunocompromised individuals.
Further complaints of white matter found in a bag of ondansetron were made by another customer. The FDA confirmed this bag was currently under analysis and added they were not aware of any reports of injuries at this time due to administration of these products.
“Claris is initiating a recall of all lots of these two products, as well as all lots of ciprofloxacin. These products were all manufactured on the same manufacturing line,” according to a statement posted on FDA's website.
Affected lots
The alert states that only metronidazole, ciprofloxacin, and ondansetron in IV bags made by Claris and sold under the Claris, Sagent, Pfizer, and West-Ward labels are affected.
While Sagent does sell IV bags of ciprofloxacin, they are not manufactured by Claris and are not subject to this recall. West-Ward does not sell an intravenous bag formulation of ciprofloxacin.
Ciprofloxacin and metronidazole are antibiotics; ondansetron is an antiemetic used to combat nausea and vomiting associated with surgery or chemotherapy.
The FDA are currently, ‘investigating the situation and will notify the public when new information becomes available.’
Speaking to the Economic Times in India, Claris said it initiated this recall as a precautionary measure against the contamination due to an integrity breach of the product packaging.
The company also said the recall was limited to products from a specific manufacturing line and specific lot numbers.
The alert by Claris is closely linked to similar events that occurred previously. Earlier this month Sagent issued a voluntary recall of certain lots of metronidazole due to ‘product nonsterility.’
The recalled lots were shipped from February to May 2010 to hospitals, wholesalers, and distributors. The FDA said at the time the affected drug may cause potentially fatal infections to immunocompromised patients.
Manufacturing capacity
The metronidazole, ondansetron, and ciprofloxacin that are at the centre of these alerts are produced on the same manufacturing line in the company's facilities in Ahmedabad, India.
Claris boasts 5 manufacturing facilities in Ahmedabad. However only some of them are approved by the FDA.
In April, the company made its intentions to go public with the view of raising enough finance to expand manufacturing capabilities to meet increasing demand.
Western Europe and North America have shifted much of its manufacturing capabilities to the East due to lower manufacturing costs, a fact made clear by Claris in its literature produced for its initial public offering.
It remains to be seen what multinational pharmaceutical companies such as Pfizer make of this latest disturbing development. Pfizer currently have arrangements in place with Indian generic drug makers to distribute their products.
Indeed, India’s pharmaceutical industry has been riding the crest of a big wave primarily because of the deals generic drug makers such as Claris have sealed with the West.
