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14 May 2016

Sanofi partial recalls of Combiflam as it fails disintegration tests

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Sanofi is recalling some batches of Combiflam as the Central Drugs Standard Control Organisation (CDSCO) found them to be not of standard quality. The batches manufactured in June 2015 and July 2015, carried expiry dates of May 2018 and June 2018 has failed disintegration tests.

Combiflam is a combination of paracetamol and ibuprofen, and is one of Sanofi’s five biggest brands in India. The tablets had delayed disintegration time which means time taken for breakdown of a tablet in the human body was unnecessarily high.Disintegration tests are used to test the time it takes for tablets and capsules to break down inside the body, and are used as a quality-assurance measure in pharmaceuticals.

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