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Several drugs used to control blood pressure were withdrawn, according to the FDA. (Courtesy: FDA)
COLUMBUS, Ohio (WSYX / WTTE) – Administration of Food and Drug says Aurobindo Pharma recalled 80 lot of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP Valsartan Tablets USP because trace amounts of unexpected impurities found in the product.
The medication is used to control high blood pressure and for the treatment of & # 39; heart failure.
FDA Commissioner Scott Gottlieb, M.D. made a series of & # 39; tweets on Wednesday morning withdrawal.
According to the FDA, the impurities found in the finished drug product is N-nitrosodiethylamine (NDEA), which is a substance that occurs with & # 39; natural way in & # 39; certain foods, drinking water, pollution & # 39; air, and industrial processes, and has been classified as probable human carcinogen according to the classification of the International Agency for Research on Cancer (IARC).
The FDA says that those taking the drug should continue taking it because of the risk of & # 39; damage to the patient can & # 39; higher if treatment is stopped immediately without any alternative treatment. Those affected should contact their pharmacist or doctor who can give advice on alternative treatment before returning to their medication.
The products were distributed throughout the country to Aurobindo Pharma USA, Inc. wholesaler, distributor, repackaging and retail customers.
Consumers b & # 39; medical questions about this withdrawal or to report an adverse event can contact Aurobindo Pharma USA, Inc. f & # 39 ;: 1-866-850-2876 or [email protected].
A complete list of & # 39; & # 39 affected products you; found online here.
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