Valsartan HCTZ recall: Impurity Out of Spec
Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-950-52
Why was Valsartan HCTZ recalled?
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: UTB23790003, exp 02/28/2019
- Product
- Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-950-52
- Recalling firm
- Northwind Pharmaceuticals LLC
- Quantity
- 43 bottles
- Distribution
- Indiana
- Recall date
- August 22, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)