FDA-Drug2018-08-22Class II
Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-950-52
Northwind Pharmaceuticals LLC
Hazard
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Sold states
Indiana
Affected count
43 bottles
Manufactured in
9402 Uptown Dr Ste 1100, Indianapolis, IN, United States
Products
Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-950-52
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1096-2018Don't want to check this manually?
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