RecallDepth
Class II Terminated

Valsartan, 80mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-0652-52

Company
Northwind Pharmaceuticals Llc
Recall Initiated
July 18, 2018
Posted
August 22, 2018
Recall Number
D-1097-2018
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
2 bottles
Firm Location
Indianapolis, IN, United States

Reason for Recall

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

Distribution

Indiana

Lot / Code Info

Lot: UT48310002, exp 10/31/2018

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