Columbus, Ohio (WSYX / WTTE) – The Food and Drug Administration says Aurobindo Pharma recalled 80 amlodipine Valsartan Tablets USP, Walsartan HCTZ Tablets, USP, and Valsartan Tablets USP due to monitoring the amount of unexpected dirt found in the product.
The drug is used to control high blood pressure and to treat heart failure.
FDA Commissioner Scott Gottlieb, MD made a series of tweets for reminding on Wednesday morning.
According to the FDA, the dirt found in the finished drug is N-nitrosodiethylamine (NDEA), a natural substance that occurs naturally in certain foods, drinking water, air pollution and industrial processes, and is classified as a likely human carcinogen according to the International Agency for Nutrition Cancer Research (IARC) classification.
The FDA says that those who take drugs should continue to take it because the risk of harm to the patient's health may be greater if the treatment is stopped immediately without alternative treatment. Affected persons should contact their pharmacist or doctor who may advise on alternative treatment before returning the drug.
The products were distributed nationwide to Aurobindo Pharma USA, Inc. wholesaler, distributor, repackager and retail customers.
Consumers with medical issues related to this reminder or report an unwanted event may appear in Aurobindo Pharma USA, Inc. at: 1-866-850-2876 or [email protected]
A full list of affected products can be found online here.