Northwind Pharmaceuticals LLC recalls Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 4
Recalled August 22, 2018 · FDA recall D-1096-2018 · Northwind Pharmaceuticals
Hazard
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. · FDA Class II
Units
43 bottles
Sold at
Indiana
Description
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Product
Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-950-52
Manufacturer(s)
Northwind Pharmaceuticals LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →