On Thursday, May 12, Sanofi recalled four batches of its painkiller, Combiflam (a combination of paracetamol and ibuprofen), in India after the country’s drug regulatory body (CDSCO) found the lots were substandard.
The Central Drugs Standard Control Organization (CDSCO), India’s regulatory body, said on its website in February and April that some of the Combiflam batches weren’t of “standard quality,” having failed disintegration tests. Used to test the time it takes for tablets and capsules to break down inside the body, these disintegration tests are a quality-assurance measure in pharmaceuticals, according to the FDA.
One article in Reuters reports that the “drug batches cited by the CDSCO were manufactured in June 2015 and July 2015, and carried expiry dates of May 2018 and June 2018.” These batches of Combiflam were manufactured at a factory in Ankleshwar, western India.
According to a one source:
A Sanofi spokeswoman told DNA India that while there was no safety issue with the drug, it was being recalled since the CDSCO had deemed it substandard. “We have acted immediately and completed the recall for two batches, while the recall of the remaining two batches is ongoing,” she said, adding that the company has already taken steps to rectify the problem.
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