Product: Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in cardboard trays  Original NDC 13668-0325-30  Repackaged NDC 70518-1220-00
Reason for recall: CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
Recall initiated: 20180824
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated