FDAFDA · Food and drugs·Recall number D-1098-2018
Valsartan, 320mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-0654-52
Published August 22, 2018 · Recall initiated: July 18, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Northwind Pharmaceuticals LLC
- Distributor
- Indiana
- Lot
- Lot: UT48100001, exp 9/30/2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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