Published: Sun, July 08, 2018
Medical | By Johnnie Horton

Europe recalls generic heart drug made in China on cancer fears

Europe recalls generic heart drug made in China on cancer fears

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.

However, it is important for people using the medicines "not to interrupt" their treatment, and the ministry recommended patients consult their doctor or pharmacist with any questions. The EMA and national agencies were working with Zhejiang Huahai Pharmaceuticals on measures to reduce or remove altogether the impurity in future batches of valsartan produced at at company's facility, the Bulgarian medicines agency said.

"In the last few hours the EMA sent a notification regarding a potential unexpected impurity found in the active pharmaceutical ingredient manufactured in China, and which is used in the manufacture of some Valsartan products", read the statement.

The Medicines and Healthcare Products Regulatory Agency (MHRA) said that patients should be switched to supplies made by other companies.

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"If you are taking any of the affected valsartan products, it is vital that you do not stop taking your medication but you should get in touch with a doctor or healthcare professional as soon as possible".

The ministry called on medicine distributors and pharmacies to stop selling all valsartan-based medicines, including VALSARTAN WIN 80 mg and 160 mg, CO-VALSARTAN WIN 80 mg/12.5mg and 16 mg/25 mg and ATENSIL 40 mg, 80 mg and 160 mg.

European regulators said they were working together to investigate the extent of the issue.

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