FDA Drug Moderate Class II Terminated

Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-950-52

Reported: August 22, 2018 Initiated: July 18, 2018 #D-1096-2018

Product Description

Reason for Recall

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

Details

Recalling Firm: Northwind Pharmaceuticals LLC
Units Affected: 43 bottles
Distribution: Indiana
Location: Indianapolis, IN

Frequently Asked Questions

What product was recalled? ▼

Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-950-52. Recalled by Northwind Pharmaceuticals LLC. Units affected: 43 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-1096-2018.

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