Recall: Teva Pharmaceuticals Amlodipine / Valsartan Combination Tablets And Amlodipine / Valsartan / Hydrochlorothiazide Combination Tablets
On 2018-11-27, the FDA announced that Teva Pharmaceuticals is conducting a recall on Amlodipine / Valsartan Combination Tablets And Amlodipine / Valsartan / Hydrochlorothiazide Combination Tablets due to a possible n-nitroso-diethylamine (ndea). The recalled products were sold under the brand name(s) Teva Pharmaceuticals 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-containing products, potassium hydrochlorothiazide tablets and more. Additionally, there have been 16 drug and medical device recalls due to other health hazards as well as 92 food recalls.
Company Contact Information:
Name: Teva Pharmaceuticals
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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 combination tablets and Amlodipine / Valsartan / Hydrochlorothiazide combination tablets
Brand Name(s): Teva Pharmaceuticals
Reason for Recall: N-nitroso-diethylamine (NDEA) Impurity
Official Recall Date: 2018-11-27
Additional information provided by the FDA.gov:
Teva Pharmaceuticals has initiated a voluntary recall in the United States, to the patient level, of all lots of Amlodipine / Valsartan combination tablets and Amlodipine / Valsartan / Hydrochlorothiazide combination tablets (see table below) due to an impurity detected above specification limits in an active pharmaceutical ingredient (API) manufactured by Mylan India. The impurity found in Mylan's valsartan API is known as N-nitroso-diethylamine (NDEA), which has been classified as a probable human carcinogen. This chemical is typically found in very small amounts in certain foods, drinking water, air pollution, and certain industrial processes. 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.