Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Defect Levels Handbook

Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100milligrams /25mg into the customer level. This item has been recalled as a result of this trace amount of an impurity, N-nitrosodiethylamine (NDEA) included at the API Losartan, USP made by Zhejiang Huahai Pharmaceutical Co. Ltd.. Sandoz Inc.. Losartan Potassium Hydrochlorothiazide merchandise is manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia. This impurity, that is a chemical which occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen according to International Agency for Research on Cancer (IARC).

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