The United States-based unit of Indian pharmaceutical company Hetero Drugs is recalling some batches of a medicine used to treat high blood pressure and heart failure, the US Food and Drug Administration has said. The valsartan medicine manufactured by the company was allegedly found to contain a potentially cancer-causing ingredient in levels more than acceptable, Reuters reported on Saturday.
The US regulator had in July started an investigation into the presence of N-nitrosodimethylamine, or NDMA, in drugs containing valsartan. Twelve companies have so far recalled some batches of valsartan. Hetero Drugs was found to be using a similar manufacturing process as the Chinese company whose product triggered the investigation, but the amount of NDMA was lower, the FDA said in a notice on Wednesday.
A spokesperson for Hetero Drugs in India refused to comment on the matter. Hetero Drugs is among India’s top 15 pharmaceutical companies and one of the largest suppliers of HIV-AIDS drugs globally, according to Reuters. It sells valsartan in the United States through its unit Camber Pharmaceuticals.
Meanwhile, India has temporarily suspended imports of medicines from China that contain valsartan, K Bangarurajan, a joint drugs controller at the Central Drugs Standard Control Organization, told Reuters on Saturday. Imports from other countries will continue, he said.