The UK's Medicines and Healthcare Products Regulatory Agency said that the medicines were made by Israeli-based Dexcel Pharma Ltd. and Accord Healthcare and are used to treat high blood pressure and heart conditions.
In the United Kingdom, the MHRA said it is advising pharmacies to recall all batches of valsartan containing medicines made by Dexcel Pharma and Accord Healthcare (previously known as Actavis Group) as a precaution.
The UK product recall was issued by the Medicines and Healthcare products Regulatory Agency (MHRA) on 5 July 2018, and a recall is underway across Europe following recent information that an impurity has been identified as part of the manufacturing process in a valsartan active substance manufactured in China.
According to worldwide media reports, the company Zhejiang Huahai found N-nitrosodimethylamine (NDMA) in the valsartan active substance supplied to manufacturers producing some of the valsartan medicines available in the European Union.
The Health Products Regulatory Authority said that patients taking some Valsartan medicines should consult their doctor or pharmacist to discuss their treatment.
The HPRA says not all valsartan medicines are affected and is reassuring patients that other treatments are available. The review was triggered after the company detected an impurity, N-nitrosodimethylamine (NDMA), a substance classified as "probable cancerogen".
According to Dr Lorraine Nolan, Chief Executive, HPRA, this is an emerging situation being managed in real time by the HPRA working with the European network of medicine regulators in order to determine the extent of the issue. "We are engaging with healthcare professionals to manage this situation".
The agency's Committee for Medicinal Products for Human Use (CHMP), is reviewing the possible impact of NDMA on patients and what steps can be taken to eliminate the impurity from future batches of product.
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