The recall of high blood-pressure drug valsartan is expanding as Indian drugmaker Aurobindo issued a voluntary recall of 80 lots of tablets of the compound due to the detection of trace amounts of an impurity found in the finished product.
The recall, which was posted on the FDA’s website, comes in the wake of months of recalls of the drug after N-nitrosodiethylamine (NDEA) was uncovered in the product. NDEA has been classified as a probable human carcinogen. To date, the company said it has not had any reports of adverse events related to the recall.
In December, Torrent Pharmaceuticals issued a voluntary recall of two lots of losartan potassium tablets after trace amounts of NDEA were found in an active pharmaceutical ingredient manufactured by Hetero Labs. Losartan is used to treat hypertension, hypertensive patients with left ventricular hypertrophy and nephropathy in Type 2 diabetes patients.
That recall came on the heels of September’s announcement that the FDA had uncovered a second and unexpected cancer-causing impurity in three batches of valsartan that Torrent sold. The regulatory agency testing triggered an inspection of the Zhejiang Huahai Pharmaceutical plant in 2017, which led to a number of recalls of the popular drug.
The FDA has said the tainted drug may have been on the market for years, and it will continue to investigate more than a dozen products that were sold in the U.S. that have been recalled.
Over the summer, the European Medicines Agency said that Huahai told them it had identified NDMA (N-nitrosodimethylamine) in valsartan sold in the European market.