FDA-Drug2018-08-22Class II

Valsartan, 80mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-0652-52

Northwind Pharmaceuticals LLC
Hazard

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Sold states
Indiana
Affected count
2 bottles
Manufactured in
9402 Uptown Dr Ste 1100, Indianapolis, IN, United States
Products
Valsartan, 80mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-0652-52

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1097-2018

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