Recall: Aurobindo Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets USP, Valsartan Tablets USP
On 2018-12-31, the FDA announced that Aurobindo Pharma USA is conducting a recall on Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets USP, Valsartan Tablets USP due to possible undeclared n-nitrosodiethylamine (ndea). The recalled products were sold under the brand name(s) Aurobindo during an unspecified time period throughout the regions shown in the map below.
In recent months, there have been 3 drugs recalls due to potential undeclared ingredients, including losartan potassium tablets, usp, dietary supplement and more. Additionally, there have been 17 drug and medical device recalls due to other health hazards as well as 95 food recalls.
Company Contact Information:
Name: Aurobindo Pharma USA
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Detailed Recall Information
Regions Where Sold: Because the region was not specified, it is assumed that this product was available nationwide.
Product Description: Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets USP, Valsartan Tablets USP
Brand Name(s): Aurobindo
Reason for Recall: Undeclared N-nitrosodiethylamine (NDEA)
Official Recall Date: 2018-12-31
Additional information provided by the FDA.gov:
Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), 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 (IARC) classification. To date, Aurobindo Pharma USA, Inc. has not received any reports of adverse events related to this recall. Read More.
More information may be available at FDA.gov
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Sources may include Food & Drug Administration (FDA), United States Department of Agriculture (USDA), Health Canada and companies involved with this or a related recall.