Valsartan tablets recalled due to detection of impurity

Henrietta Brewer
July 20, 2018

NDMA is a potential human carcinogen, which means long-term exposure to it could cause cancer, according to the International Agency for Research on Cancer.

Zhejiang Huahai Pharmaceutical - a major supplier of the active ingredient valsartan that it uses to make a generic blood pressure drug - raised the alarm and voluntarily suspended its supplies in the worldwide market after detecting an impurity, N-nitrosodimethylamine (NDMA) in the product. If the information is not there, patients should contact the pharmacy where they got it, the FDA said.

Ministry of Health also has directed all to to stop using anything that contains the concerned chemical from the mentioned company.

Zhejiang Huahai has already acknowledged that there was an impurity in some of its valsartan, which it said had sales of $50 million in 2017. Patients who are on valsartan should continue taking their medication, as the risk of harm to a patient's health may be higher if the treatment is stopped immediately without any alternative treatment.

In his statement, FDA Commissioner Dr. Scott Gottlieb said his "drug shortages team is also working hard to ensure patients' therapeutic needs are met in the United States with an adequate supply of unaffected medications". The FDA noted not all products containing valsartan are contaminated and being recalled.

The review was conducted at the request of the European Commission after the company detected N-nitrosodimethylamine in valsartan's active pharmaceutical ingredient possibly as a result of changes to the way it is manufactured.

As valsartan is used to treat various cardiovascular conditions including heart failure and hypertension, patients should continue to take their medications until they have a replacement product.

The Food and Drug Administration reports that Teva Pharmaceuticals USA has issued a voluntary recall of one of its medications.

The ingredient was supplied by a third-party.

The Ministry of Health is assuring the public that Valsartan products in Barbados have not been affected by an worldwide recall. The recent detection of higher levels of NDMA in raw materials imported from a particular supplier in China (Zheijhiang Huahai Pharmaceuticals Linhai China) indicates improper processes and poor monitoring at the suppliers facility. The companies recalling their products include Major Pharameceuticals, Solco Healthcare and Teva Pharmaceuticals Industries Ltd.

The FDA points out that not all products containing valsartan are being recalled.

This information will be posted on the FDA's website.

Other reports by iNewsToday