Recall: Torrent Pharma Losartan Potassium Tablets USP
On 2019-01-03, the FDA announced that Torrent Pharmaceuticals Limited is conducting a recall on Losartan Potassium Tablets USP due to a possible n-nitrosodiethylamine (ndea). The recalled products were sold under the brand name(s) Torrent Pharma during an unspecified time period throughout the regions shown in the map below.
In recent months, there have been 7 drugs recalls due to potential elevated impurity, including valsartan tablets, usp, amlodipine and valsartan tablets, usp, and valsartan and hydrochlorothiazide tablets, amlodipine / valsartan combination tablets and amlodipine / valsartan / hydrochlorothiazide combination tablets and more. Additionally, there have been 13 drug and medical device recalls due to other health hazards as well as 91 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: Losartan potassium tablets USP
Brand Name(s): Torrent Pharma
Reason for Recall: Elevated Impurity of N-nitrosodiethylamine (NDEA)
Official Recall Date: 2019-01-03
Additional information provided by the FDA.gov:
Torrent Pharmaceuticals Limited is expanding its voluntary recall from 2 lots of Losartan potassium tablets USP to a total of 10 lots, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. Torrent is only recalling lots of losartan-containing products that contain N-nitrosodiethylamine (NDEA) above the acceptable daily intake levels released by the FDA. 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.