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Drug Safety Alerts
Mylan Valsartan Products Consumer-Level Recall
11/20/2018
On November 20, 2018, Mylan issued a consumer-level recall of amlodipine and valsartan tablets, valsartan tablets and valsartan and hydrochlorothiazide tablets.On December 4, 2018, Mylan issued an expanded consumer-level recall to include all lots. This recall was issued 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 U.S. between March 2017 and November 2018.
A complete list of the affected products is provided here.
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. The United States Food and Drug Administration (FDA) recommends that 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 patient's health may be higher if the treatment is stopped immediately without any alternative treatment.
CVS Caremark Response: Because of this action, CVS Caremark Mail Service Pharmacy contacting patients and prescribers to advise them of this recall. We are encouraging patients who are taking amlodipine and valsartan tablets, valsartan tablets and valsartan and hydrochlorothiazide tablets to contact their prescriber.
For more information about this recall, please contact Mylan Pharmaceuticals at 800.796.9526 800.796.9526 800.796.95261-800-796-9526 or visit http://newsroom.mylan.com/.
You may also contact the FDA consumer inquiry line at 1‑888‑INFO-FDA (1‑888-463-6332) or visit https://www.fda.gov.