Recall: Mylan Valsartan Tablets, USP, Amlodipine And Valsartan Tablets, USP, And Valsartan And Hydrochlorothiazide Tablets
On 2018-12-04, the FDA announced that Mylan is conducting a recall on Valsartan Tablets, USP, Amlodipine And Valsartan Tablets, USP, And Valsartan And Hydrochlorothiazide Tablets due to a possible ndea (n-nitrosodiethylamine). The recalled products were sold under the brand name(s) Mylan during an unspecified time period throughout the regions shown in the map below.
In recent months, there have been 6 drugs recalls due to potential elevated impurity, including amlodipine / valsartan combination tablets and amlodipine / valsartan / hydrochlorothiazide combination tablets, valsartan-containing products and more. Additionally, there have been 15 drug and medical device recalls due to other health hazards as well as 90 food recalls.
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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 Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets
Brand Name(s): Mylan
Reason for Recall: Presence of NDEA (N-Nitrosodiethylamine)
Official Recall Date: 2018-12-04
Additional information provided by the FDA.gov:
Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within expiry. The 104 additional lots include 26 lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths), 51 lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg and 320 mg strengths), and 27 lots of Valsartan and Hydrochlorothiazide Tablets, USP (80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg and 320mg/25mg strengths). 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.