Prinston Pharmaceutical Inc is recalling approximately 154,468 bottles of Irbesartan and Irbesartan/Hydrochlorothiazide combination tablets, used to treat high blood pressure. Testing by the FDA confirmed the presence of N-nitrosodimethylamine (NDEA), an impurity in the active ingredient that exceeds acceptable daily intake levels. These prescription medications were manufactured by Zhejiang Huahai Pharmaceutical Co. in China and distributed nationwide under the Solco Healthcare US, LLC label.
NDEA is classified as a probable human carcinogen, meaning long-term exposure above acceptable levels may increase the risk of cancer. While no immediate injuries or illnesses have been reported, the levels found in these specific batches exceed safety thresholds set by the FDA.
Pharmaceutical product return
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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