The United States Food and Drug Administration said that Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level.
FDA announced voluntary recall of several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure.
FDA said that the recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer - Zhejiang Huahai Pharmaceutical Co. Ltd. This impurity has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.
The US recall includes versions of valsartan that are made by Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries Ltd. as well as valsartan/hydrochlorothiazide (HCTZ) sold by Solco Healthcare and Teva Pharmaceuticals Industries Ltd.
We have carefully assessed the valsartan-containing medications sold in the United States, and we've found that the valsartan sold by these specific companies does not meet our safety standards, said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, in a statement.