FDA Alerts to Recall of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP by Aurobindo

Published: 01/03/2019

Sources:
  • Food and Drug Administration
Relevant To:
  • All Healthcare Organizations

The U.S. Food and Drug Administration (FDA) is informing healthcare professionals of the following:

  • Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which is a substance that occ

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