19 July 2018 - - US-based Teva Pharmaceuticals USA, part of Petach Tikva, Israel-based generic and specialty medicines company Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) (TASE: TEVA), has confirmed a voluntary recall to the consumer / user level of 29 lots of single and 51 lots of combination valsartan medicines distributed under the Actavis label in the US due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceutical, the company said.
The impurity detected in the API is N-nitrosodimethylamine, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer classification.
Valsartan is used for the treatment of hypertension (high blood pressure) and for the treatment of heart failure. It is also indicated as a treatment for left ventricular failure and left ventricular dysfunction following myocardial infarction. In combination with hydrochlorothiazide, it is used in the treatment of hypertension.
This recall is being conducted with the full knowledge of the US Food and Drug Administration. To date, TEVA has not received any reports of adverse events related to this recall.
Teva Pharmaceutical Industries is a patient-centric healthcare solutions, and generic and specialty medicines producer.
It leverages its portfolio of more than 1,800 molecules to produce a range of generic products in nearly every therapeutic area.
In specialty medicines, the company has an innovative treatment for multiple sclerosis as well as late-stage development programmes for other disorders of the central nervous system, including movement disorders, migraine, pain and neurodegenerative conditions, as well as a broad portfolio of respiratory products.