Recall: Torrent Valsartan/Amlodipine/HCTZ Tablets
On 2018-08-17, the FDA announced that Torrent Pharmaceuticals Limited is conducting a recall on Valsartan/Amlodipine/HCTZ Tablets due to a possible n-nitrosodimethylamine (ndma). The recalled products were sold under the brand name(s) Torrent during an unspecified time period throughout the regions shown in the map below.
In recent months, there have been 4 drugs recalls due to potential elevated impurity, including valsartan tablets, usp, 40mg, 80mg, 160mg and 320mg, valsartan and valsartan hydrochlorothiazide tablets and more. Additionally, there have been 20 drug and medical device recalls due to other health hazards as well as 77 food recalls.
Company Contact Information:
Name: Torrent Pharmaceuticals Limited
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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: Valsartan/Amlodipine/HCTZ tablets
Brand Name(s): Torrent
Reason for Recall: elevated Impurity of N-nitrosodimethylamine (NDMA)
Official Recall Date: 2018-08-17
Additional information provided by the FDA.gov:
Torrent Pharmaceuticals Limited is voluntarily recalling 14 lots of Valsartan/Amlodipine/HCTZ tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), 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. 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.