Product: Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701
Reason for recall: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated: 20180717
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated