American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

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Ottogi America, Inc. Issues Recall

American Health Packaging is voluntarily recalling one lot of Valsartan Tablets, USP, 160 mg into the consumer level as a result of discovery of trace amounts of an unexpected impurity found in the final drug product. The impurity found in the final drug product is N-Nitrosodiethylamine (NDEA), which is a chemical that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen according to International Agency for Research on Cancer (IARC) classification. This recall has been initiated in response to the recall by the manufacturer (Aurobindo Pharma USA, Inc.), which comprised the affected lot that was repackaged by American Health Packaging.



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