The USFDA has classified the action for Aurobindo Pharma as a Class II recall, and for Lupin, the health regulator classified the recall as class III
Aurobindo Pharma 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.
Besides, Mumbai-based Lupin is also recalling 3,200 bottles of Testosterone Topical solution in the US for issues with the container.
As per the latest Enforcement Report issued by the US Food and Drug Administration (USFDA), Aurobindo Pharma USA Inc is recalling the drug in various strengths due to “presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the active pharmaceutical ingredient (API) which is used to manufacture the product.”
The company, which is a subsidiary of Hyderabad-based Aurobindo Pharma, 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 has distributed the product to major distribution chains throughout the US, USFDA said.
The US health regulator has classified the action as a Class-II recall, which is initiated in a “situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote”.
Baltimore-based Lupin Pharmaceuticals Inc, a part of Lupin, is also recalling 3,200 bottles of Testosterone Topical Solution in the US.
USFDA said repetitive complaints were received regarding the container indicating faulty pump.
The product was distributed to seven major wholesale/drug chain distributors and one supermarket chain that may have further distributed the product throughout the US, USFDA said in its report.
The US health regulator classified it as class III recall, which is initiated in a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.