The recall is for products which are above the interim acceptable intake level of 0.27 parts per million. The medicines are used for controlling high blood pressureRecently, Hyderabad-based Aurobindo Pharma initiated a similar recall of 80 lots of Valsartan. Last month, the US agency in a press statement said that NDMA and NDEA are probable human carcinogens and should not be present in drug products. Drug products that contain NDMA or NDEA above the limits in the table below pose an unacceptable risk to patients," the drug regulator said in its statement. "The presence of impurities in Valsartan medicines and other sartans is thought to be linked to the synthesis of a specific ring structure (tetrazole) which is present in some sartan medicines.

Source: dna January 08, 2019 23:37 UTC