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The Medicines and Health Products Regulatory Agency (MHRA) urged UK pharmacies to recall all batches of Valsartan drugs as a precaution, fearing that an impurity would compromise the process of manufacturing in a factory in China.
has published its recall of the drugs containing valsartan manufactured by Dexcel Pharma Ltd and Accord Healthcare as a result of a European-wide recall of the drug used to treat high blood pressure and diseases heart.
The impurity was identified in relation to the manufacturing process in a valsartan active substance. The MHRA warned that the impurity, N-nitrosodimethylamine, could have a "carcinogenic potential".
"This active substance is used in a number of drugs marketed in Europe," said the regulator
. EU regulators work together to study the extent of the problem and any possible impact for patients.
"If you are taking any of the affected valsartan products, it is essential that you do not stop taking your medications, but you should come in contact with a doctor or health care professional as soon as possible.
"Alternative products containing valsartan, which are not affected by this problem, are available in the United Kingdom."
Dr. Sam Atkinson, Director of Inspection, The Standards Division of the MHRA said: "It is advisable for people taking valsartan medications affected by this recall not to stop taking their medications, but to talk to their doctor or health care professional who can advise them on the alte.
"We continue to undertake an urgent review of all these products which may pose a low risk to public health."
"We will report the results of our investigations and ensure that all other products concerned are recalled. Our highest priority is to make sure that the medications you are taking are safe.
"If you are concerned, talk to your general practitioner, pharmacist or other health professional and we strongly encourage anyone taking Valsartan medicines to report any suspected side effects via our yellow card system." [19659012]
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