The US Food and Drug Administration (FDA) has announced a voluntary recall of several drug products containing the active ingredient, valsartan, which is used to treat high blood pressure and heart failure. Three companies are involved in the recalls: Teva Pharmaceutical Industries, Major Pharmaceuticals, a Livonia, Michigan-based generic pharmaceutical provider, and Solco Healthcare, a Cranbury, New Jersey-based generic pharmaceutical provider.

The recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. Not all products containing valsartan are being recalled, however. NDMA is classified as a probable human carcinogen based on results from laboratory tests. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured, according to information from the FDA.

The FDA’s review is ongoing and has included investigating the levels of NDMA in the recalled products, assessing the possible effect on patients who have been taking them, and what measures can be taken to reduce or eliminate the impurity from future batches produced.

Earlier this month (July 2018) the European Medicines Agency (EMA) initiated a recall of the active substance, valsartan, supplied by Zhejiang Huahai Pharmaceuticals, a Linhai, China-based pharmaceutical company. As the substance is being recalled, the EMA is reviewing all medicines from the company containing valsartan. The review began after the company detected the impurity NDMA in the active substance.

Source: FDA