Valsartan HCTZ 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 HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN…
- Recall number
- D-1096-2018
- 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 HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-950-52
Get recall alerts
Free email alert whenever Northwind Pharmaceuticals LLC has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Northwind Pharmaceuticals LLC