Valsartan recalled over manufacturing violations
- Recall date
- July 18, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Northwind Pharmaceuticals LLC recalls Valsartan, 320mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC…
- Recall number
- D-1098-2018
- FDA classification
- Class II
- Brand / firm
- Northwind Pharmaceuticals LLC
- Sold / distributed
- Indiana
Why it was recalled
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Valsartan, 320mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-0654-52
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