Valsartan, 320mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-0654-52
Reported: August 22, 2018 Initiated: July 18, 2018 #D-1098-2018
Product Description
Valsartan, 320mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-0654-52
Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Details
- Recalling Firm
- Northwind Pharmaceuticals LLC
- Units Affected
- 14 bottles
- Distribution
- Indiana
- Location
- Indianapolis, IN
Frequently Asked Questions
What product was recalled? ▼
Valsartan, 320mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-0654-52. Recalled by Northwind Pharmaceuticals LLC. Units affected: 14 bottles.
Why was this product recalled? ▼
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 22, 2018. Severity: Moderate. Recall number: D-1098-2018.
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