‘SUBSTANDARD’ COMBIFLAM FAILS QUALITY TEST, RECALLED
NEW DELHI: French drug maker Sanofi is recalling batches of its popular painkiller Combiflam in India after the concerns flagged by country’s apex drug regulation body, Central Drugs Standard Control Organisation (CDSCO).
CDSCO has found that the lots were substandard, and said in notices posted on its website in February and April that it had found some batches of Combiflam to be “not of standard quality” as they failed disintegration tests.
Combiflam is a combination of paracetamol and ibuprofen, and is one of Sanofi’s five biggest brands in India, according to the company’s latest available annual report dated March 2015. “Some batches of Combiflam tablets were found to have a delayed disintegration time. There is a pharmaceutical parameter that requires the breakdown of a tablet in the human body to be assessed,” said Sanofi India spokesperson.
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