Product: Valsartan Tablets, 160 MG, 30-count bottle (NDC 54569-6583-0), 90-count bottle (NDC 54569-6583-1), Rx Only, MFG: Zhejiang Huahai Pharma, Linhai, Zhejiang 317024 China
Reason for recall: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated: 20180717
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated