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Home > Recalled Products > Drugs > Elevated Impurity > Mylan Valsartan-containing Products

Recall: Mylan Valsartan-containing Products

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On 2018-11-20, the FDA announced that Mylan Pharmaceuticals is conducting a recall on Valsartan-containing Products due to a possible n-nitrosodiethylamine (ndea). 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 4 drugs recalls due to potential elevated impurity, including potassium hydrochlorothiazide tablets, irbesartan tablets and more. Additionally, there have been 20 drug and medical device recalls due to other health hazards as well as 84 food recalls.

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Label, Amlodipine and Valsartan Tablets, 5mg/160mg
Note: Images may not be available for every version. Please review the detailed description below.

Company Contact Information:

Name: Mylan Pharmaceuticals
Website: http://www.mylan.com/
Phone: 888-406-9305

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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-containing Products

Brand Name(s): Mylan

Reason for Recall: Contain trace amounts of an impurity, N-nitrosodiethylamine (NDEA)

Official Recall Date: 2018-11-20


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Additional information provided by the FDA.gov:

Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength. These products are being recalled due to detected trace amounts of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Valsartan, USP, manufactured by Mylan Laboratories Limited. NDEA 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 according to the International Agency for Research on Cancer (IARC). 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.

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