Teva Pharmaceuticals has initiated a voluntary recall in the USA, to the patient level, of all lots of Amlodipine / Valsartan combination tablets and Amlodipine / Valsartan / Hydrochlorothiazide combination tablets due to an impurity detected above specification limits in an active pharmaceutical ingredient (API) manufactured by Mylan (India).
The impurity found in Mylan’s valsartan API is known as N-nitroso-diethylamine (NDEA), which has been classified as a probable human carcinogen. This chemical is typically found in very small amounts in certain foods, drinking water, air pollution, and certain industrial processes. Amlodipine/Valsartan combination tablets and Amlodipine/Valsartan/Hydrochlorothiazide combination tablets are used for the treatment of high blood pressure. To date, Teva has not received any reports of adverse events signaling a potential link or exposure to valsartan. Patients are advised to continue taking their medication and to contact their pharmacist or physician for advice on alternative treatment.
Earlier this month, authorities in the EU took action after an impurity was found in some batches of valsartan made by Mylan Laboratories Limited in Hyderabad (India).
This issue is not limited to valsartan medicines manufactured and distributed by Teva. Some valsartan-containing products manufactured and distributed by other pharmaceutical companies using the same API supplier may also be affected.