Valsartan, 320mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-0654-52
Recall Number: D-1098-2018
Firm: Northwind Pharmaceuticals LLC
Classification: Class II
Status: Terminated
Report Date: 20180822
Initiation Date: 20180718
Termination Date: 20230325
Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Product Description
Valsartan, 320mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-0654-52