Certain medicines containing the active pharmaceutical ingredient, valsartan, have been recalled by the South African Health Products Regulatory Authority (Sahpra) due to an impurity that was found at one of the manufacturing facilities in China that produces the molecule.
The molecule was recalled across several international markets including the USA and Europe as many originator and generic suppliers source valsartan from the same manufacturer.
The presence of the impurity, N-nitrosodimethylamine (NDMA), could be linked to changes in the way the active substance was manufactured, but a thorough investigation is currently underway to determine the exact cause. The NDMA is classified as a probable human carcinogen (carcinogen is any substance that when exposed to living tissue may cause the production of causing cancer) based on the results from laboratory tests, Sahpra said.
It stated that it will continue to investigate and assess whether the impurity may p
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