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Aurobindo Phrama USA has initiated a voluntary nationwide consumer level recall expansion of 38 lots of Amlodipine Valsartan tablets USP and Valsartan Tablets, USP due to the detection of NDEA (N-Nitrosodiethylamine) impurity.
The pharma company is conducting a voluntary recall expansion of 38 lots of Valsartan and Amlodipine Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product.
This recall is an expansion of the recall initiated on December 31, 2018.
The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification, according to a company statement.
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