May 13th, 2016
The popular painkiller that is found in almost every household, Combiflam, has been withdrawn in India by drug major Sanofi after the country’s drugs regulator found the lots substandard.
The company decide to withdraw the drug after it failed the disintegration test, which led the Central Drugs Standard Control Organisation (CDSCO) to call the batch “not of standard quality”.
Some batches of Combiflam manufactured in June-July 2015 (expiry May-June 2018) were found taking more disintegration time. Disintegration refers to the time that a drug takes once inside the body to break up into granules of a minimum specified size which is essential for it to start.
However, the Sanofi spokesperson said that it won’t have any impact on a patient’s safety. Anyone can still pop the pill if he or she feels excessive muscle pain. You have to only check the manufacture and expiry dates.
Combiflam, which is a combination of paracetamol and ibuprofen will be sold without any bar in the market. It is one of Sanofi’s five largest brands in India. The company has assured appropriate remedial steps have been taken to ensure that the tablets disintegrate in specific timelines.
Sanofi recalls some batches of painkiller Combiflam in India https://t.co/Kxw107SSP2
— Reuters India (@ReutersIndia) May 12, 2016
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