Product: Valsartan and Hydrochlorothiazide Tablets, Valsartan 160 MG and Hydrochlorothiazide 12.5 MG, 90 tablets per bottle, Rx Only, MFG: Arrow Pharm (Malta) LTD, Birzebbugia, BBG 3000 Malta. NDC: 54569-6480-0
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