Aurobindo Pharma’s subsidiary -- Aurobindo Pharma USA Inc is recalling multiple lots of blood pressure lowering drugs in the US after the American health regulator found certain deviations from Current Good Manufacturing Practice (CGMP) regulations. As the presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the active pharmaceutical ingredient (API) which used to manufacture the product.
The company has initiated a voluntary recall for some lots of Valsartan tablets in strengths of 320 mg, 80 mg, 160 mg in 90 count bottles and 40 mg tablets in 30 count bottles. It is also recalling certain lots of Amlodipine and Valsartan Tablets USP 10mg/160mg in 30 count bottles for CGMP deviations.
Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.
