Valsartan, 80mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indian...
FDA Recall #D-1097-2018 — Class II — July 18, 2018
Product Description
Valsartan, 80mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-0652-52
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
2 bottles
Distribution
Indiana
Code Information
Lot: UT48310002, exp 10/31/2018
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated