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Prinston – Recall of Irbesartan-Containing Products

January 18, 2019 - Prinston announced a voluntary, patient-level recall of several lots of irbesartan and irbesartan/hydrochlorothiazide (HCTZ) tablets due to the detection of trace amounts of an unexpected impurity, identified as N-nitrosodiethylamine (NDEA), found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals.

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