Hyderabad-based Aurobindo Pharmaceuticals is recalling nearly 5 lakh bottles of blood pressure lowering drug after US Food and Drug Administration (USFDA), according to its latest report, found the presence of a probable carcinogen in the drug.
The USFDA said that the US arm of Aurobindo Pharma, Aurobindo Pharma USA, Inc. would voluntarily recall various batches of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP. These drugs were found to contain traces of N-Nitrosodiethylamine (NDEA) in one of their ingredients.
The drug regulator further says that NDEA has been identified as a possible carcinogen by the International Agency for Research on Cancer (IARC). The USFDA has said that the presence of NDEA above the daily acceptable limit of 0.083 parts per million can cause adverse health effects. It may be noted that NDEA is naturally found in various foods, drinking water, air pollutants and industrial products.
Aurobindo Pharma's US arm has been asked to recall the BP-lowering drugs from distributors, retailers, wholesalers. They have further been tasked with notifying the distributors and customers on phone or in writing to discontinue the sale, distribution and consumption of these drugs.
Although, the drug regulator has not received any reports of adverse health consequences by patients who are taking this generic drug, the patients who are consuming it have been advised to gradually stop its use and switch to alternative medications.
The US drug authority has called it a Class II recall where the presence of a certain product may result in temporary adverse health side-effects or where the probability of serious health-damaging consequences is remote.
Notably, US is one of the biggest markets of BP-lowering drugs worldwide with more than half of the hypertension patients worldwide, present in the country.
Indian pharma companies have been cashing in on the US pharma market accounting for $6 billion pharma exports to the country, according to the Union ministry of commerce.
However, the Indian pharma companies are often found guilty of violating the current good manufacturing practice( CGMP), at their manufacturing plants. Recently another Indian drug firm, Lupin recalled more than 7,000 bottles of Cephalexin Oral Suspension bottles used in the treatment of bacterial infections. This came after the US drug regulator said that the bottles did not have a manufacturing record, again violating CGMP.
Meanwhile, the shares of Aurobindo Pharma traded at Rs 758.5 at 1.04 pm on Monday, January 28, witnessing a 3.18 per cent dip from the previous close of Rs 783.40 on the Bombay Stock Exchange (BSE).