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Home > Recalled Products > Drugs > Elevated Impurity > Prinston Pharmaceutical Irbesartan And Irbesartan HCTZ Tablets

Recall: Prinston Pharmaceutical Irbesartan And Irbesartan HCTZ Tablets


On 2019-01-18, the FDA announced that Prinston Pharmaceutical , dba Solco Healthcare is conducting a recall on Irbesartan And Irbesartan HCTZ Tablets due to a possible n- nitrosodiethylamine (ndea). The recalled products were sold under the brand name(s) Prinston Pharmaceutical during an unspecified time period throughout the regions shown in the map below.

In recent months, there have been 8 drugs recalls due to potential elevated impurity, including losartan potassium tablets usp, valsartan tablets, usp, amlodipine and valsartan tablets, usp, and valsartan and hydrochlorothiazide tablets and more. Additionally, there have been 13 drug and medical device recalls due to other health hazards as well as 76 food recalls.

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Label, Irbesartan Tablets 300 mg, 90 count bottle
Note: Images may not be available for every version. Please review the detailed description below.

Company Contact Information:

Name: Prinston Pharmaceutical , dba Solco Healthcare
Phone: 888-871-7116

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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: Irbesartan and Irbesartan HCTZ Tablets

Brand Name(s): Prinston Pharmaceutical

Reason for Recall: Elevated Impurity of N- nitrosodiethylamine (NDEA)

Official Recall Date: 2019-01-18


Additional information provided by the

Prinston Pharmaceutical Inc., dba Solco Healthcare LLC., has initiated a voluntary recall of one (1) lot of Irbesartan and seven (7) lots of Irbesartan HCTZ Tablets to the consumer level due to the detection of trace amount of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. Read More.

More information may be available at

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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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