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API contained an impurity, N-nitrosodiethylamine, a probable human carcinogen
November 14, 2018
By: Kristin Brooks
Managing Editor, Contract Pharma
Sandoz Inc. is voluntarily recalling one lot of hypertension drug Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA) contained in the API. Losartan API USP is manufactured by Zhejiang Huahai Pharmaceutical Co. Sandoz Losartan Potassium Hydrochlorothiazide product is manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia. The impurity, a substance that occurs naturally in certain foods, dri...
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