This is the sixth valsartan drug that has been recalled in the US because of the impurities in its key ingredient
A key pharma ingredient manufactured by Mylan in India, used in blood pressure drug Valsartan, is detected with a suspected carcinogen, resulting in sixth voluntary recall of the drug by pharma companies in the United States.
In a recent notification on the US Food and Drug Administration (USFDA) website, Teva Pharmaceuticals has initiated a voluntary nationwide recall of all lots of Amlodipine and Valsartan combination tablets and Amlodipine, Valsartan and Hydrochlorothiazide combination tablets due to an impunity detected above specification limits in an active pharmaceutical ingredient (API) manufactured by Mylan.
This is the sixth valsartan drug that has been recalled in the US because of the impurities in its key ingredient. The impurity found in Mylan's valsartan key ingredient is known as N-nitroso-diethylamine (NDEA) that has been classified as a probable human carcinogen.
The chemical is typically found in very small amounts in certain foods, drinking water, air pollution, and certain industrial processes. The tablets are used for the treatment of high blood pressure.
Teva, which is recalling a total 49 lots, said it has not received any reports of adverse events signalling a potential link or exposure to Valsartan.
Patients taking the medicines are, however, advised to continue taking their medication and to contact their pharmacist or physician for advice on alternative treatment, the notification said, adding that the risk of harm to a patient's health may be higher if the treatment is stopped immediately without any comparable alternative treatment.
In August, Ahmedabad-based Torrent Pharmaceuticals recalled 14 lots of Valsartan in the US, as its key ingredient manufactured by a Chinese bulk drug producer was detected of impurity N-nitrosodimethylamine (NDMA), classified as another probable human carcinogen.
Last month, Aurobindo Pharma has also recalled 22 lots of hypertension drug Irbesartan due to the presence of NDEA. The company has supplied the key ingredient to ScieGen Pharmaceuticals Inc, US for the manufacturing of finished Irbesartan drug product.
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