Mylan NV announced that its US based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within expiry The 104 additional lots include 26 lots of Amlodipine and Valsartan Tablets USP including the 5mg 160mg 10mg 160mg 5mg 320mg and 10mg 320mg strengths 51 lots of Valsartan Tablets USP including 40 mg 80 mg 160 mg and 320 mg strengths and 27 lots of Valsartan and Hydrochlorothiazide Tablets USP 80mg 125mg 160mg 125mg 160mg 25mg 320mg 125mg and 320mg 25mg strengths Out of an abundance of caution these products are being recalled due to detected trace amounts of an impurity N-nitrosodiethylamine NDEA contained in the API Valsartan USP manufactured by Mylan Laboratories Limited NDEA 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 according to the International Agency for Research on Cancer IARC The finished products are manufactured by Mylan Pharmaceuticals Inc and Mylan Laboratories Limited These batches were distributed in the US between March 2017 and November 2018 Valsartan is used for the treatment of high blood pressure for the treatment of heart failure and to reduce cardiovascular mortality following myocardial infarction Valsartan in combination with amlodipine or hydrochlorothiazide is used for the treatment of high blood pressure Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication Patients who are on valsartan should continue taking their medication as the risk of harm to the patients health may be higher if the treatment is stopped immediately without any alternative treatment Mylan is notifying its distributors and customers by letter and is arranging for return of all recalled products Wholesalers retailers and consumers that are in possession of recalled product should contact Stericycle at 1-888-406-9305 for the return of the recalled product Normal business hours are Monday through Friday 8 am to 5 pm EST Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products Subscribe to our e-Newsletters Stay up to date with the latest news articles and events Plus get special offers from American Pharmaceutical Review all delivered right to your inbox Sign up now