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Regulatory Focus™ > News Articles > 7 > EU Recalls Some Valsartan Medicines Over Impurity

EU Recalls Some Valsartan Medicines Over Impurity

Posted 06 July 2018 | By Ana Mulero 

EU Recalls Some Valsartan Medicines Over Impurity

EU authorities have initiated a recall of certain valsartan-containing medicines supplied by China-based Zhejiang Huahai Pharmaceuticals, pending a European Medicines Agency (EMA) review of an impurity detected.
The presence of the N-nitrosodimethylamine (NDMA) impurity—classified as a probable human carcinogen—in the company’s high blood pressure and heart drugs “was unexpected and is thought to be related to changes in the way the active substance was manufactured,” EMA said.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) is charged with conducting the review, per the European Commission’s (EC) request, of the active substance.
The review involves investigating the “levels of NDMA in these valsartan medicines, its possible impact on patients who have been taking them and what measures can be taken to reduce or eliminate the impurity from future batches produced by the company,” EMA added. “As a precaution, the review will also consider whether other valsartan medicines may be affected.”
CHMP’s opinion will be used by the EC to make a legally binding decision, following the review.
Last year, the EMA recommended the suspension of 300 generic drugs, some of which included valsartan, “due to unreliable studies” to serve as a basis for EU marketing clearances. The active substance was originally developed by Novartis as Diovan until a 2012 patent loss.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) also issued a warning Thursday advising local pharmacies to recall all valsartan-containing medicines manufactured by Decel Pharma and Accord Healthcare as these had been supplied by Zhejiang Huahai.


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