Sartans Recalled In UK As Further Impurity Is Confirmed
Follows 2018 Europe-Wide Nitrosamines Crisis
Certain batches of two angiotensin II receptor blockers, or sartans, are being recalled in the UK after an impurity that can potentially increase the risk of cancer over time was detected.
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The EMA is launching an initiative aimed at preventing impurities in medicines and better handling cases where impurities do occur, following the agency’s experiences in dealing with sartans that contained nitrosamine impurities.
As Zhejiang Huahai works to rid its valsartan API manufacturing process of NDMA impurity, two competitors also have launched recalls after discovering the probable carcinogen in their valsartan API. Meanwhile, US FDA confronts Huahai over handling of impurities that visited chromatograms in the form of ghost peaks.
Hundreds of marketing authorisations held by major generics players – including Accord’s Actavis, Aurobindo, Gedeon Richter, Sandoz, Sanofi’s Zentiva, and Teva – have been affected by recalls across Europe of medicines containing valsartan, prompted by the discovery of an impurity in the active pharmaceutical ingredient (API) supplied by China’s Zhejiang Huahai. Health Canada has also issued a recall.