Pfizer recalls Indian-made intravenous drugs
pharmafile | June 7, 2010 | News story | Manufacturing and Production | Claris Lifesciences, Pfizer, manufacturing compliance, recalls
Pfizer is recalling two intravenous antibiotics and an anti-nausea medication after particulate matter was found to be floating in them, leading to concerns they may not be sterile and could put patients at risk.
“Non-sterility of a product administered via the intravenous route has the potential to result in infections, which could be fatal, especially in patients who are immunocompromised,” the company said in a statement.
The case adds to a growing catalogue of recalls due to contamination and other production defects, and comes as another big pharma company – Johnson & Johnson – is facing difficult questions about the standard of its own manufacturing operations.
Pfizer’s recall concerns four lots of intravenous bag formulations of metronidazole, ciprofloxacin and ondansetron manufactured by Indian company Claris Lifesciences.
The products distributed in the US by Pfizer under the terms of a non-exclusive licensing agreement signed by the two companies earlier this year, and also by other drugmakers including Sagent Pharmaceuticals, West-Ward Pharmaceuticals and by Claris itself.
Pfizer said that it has halted distribution of all sterile injectable products in intravenous bags licensed from Claris Lifesciences and is voluntarily recalling products already distributed.
A total of 1.7 million IV bags have been licensed for distribution from Claris, said Pfizer, adding that approximately 1.3 million, or about 80%, are still in its control.
Meanwhile, Canadian pharmaceutical company BioSyent announced its own recall of intravenous ciprofloxacin infusion product made by Claris Lifesciences as a precautionary measure.
There have been reports – as yet unconfirmed – that the floating matter was a Cladosporium species of mould, according to a report on the website of US regulator the FDA.
“Another customer complaint of white matter in a bag of ondansetron was received, and that bag is currently under analysis,” said the agency.
All the products are believed to have been made on the same production line at one of Claris Lifesciences five Indian manufacturing facilities in Ahmedabad.
Both Pfizer and Claris Lifesciences said they were not aware of anyone being harmed by the products, but are carefully monitoring the situation. They have asked their customers to review their inventories and immediately remove any products from the affected lots.
Phil Taylor
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