Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceutic...
FDA Recall #D-1096-2018 — Class II — July 18, 2018
Product Description
Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-950-52
Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recalling Firm
Northwind Pharmaceuticals LLC — Indianapolis, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
43 bottles
Distribution
Indiana
Code Information
Lot: UTB23790003, exp 02/28/2019
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated