Recall: Torrent Pharmaceuticals Limited Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine And Valsartan Tablets
On 2018-08-21, the FDA announced that Torrent Pharmaceuticals Limited is conducting a recall on Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine And Valsartan Tablets due to a possible n-nitrosodimethylamine (ndma). The recalled products were sold under the brand name(s) Torrent Pharmaceuticals Limited during an unspecified time period throughout the regions shown in the map below.
In recent months, there have been 5 drugs recalls due to potential elevated impurity, including valsartan/amlodipine/hctz tablets, valsartan tablets, usp, 40mg, 80mg, 160mg and 320mg and more. Additionally, there have been 20 drug and medical device recalls due to other health hazards as well as 76 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, Valsartan/Amlodipine and Valsartan tablets
Brand Name(s): Torrent Pharmaceuticals Limited
Reason for Recall: Elevated Impurity of N-nitrosodimethylamine (NDMA)
Official Recall Date: 2018-08-21
Additional information provided by the FDA.gov:
Torrent Pharmaceuticals Limited is voluntarily recalling ALL LOTS within expiry of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan 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.