Reported Aug 22, 2018 · Terminated
Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN…
Northwind Pharmaceuticals LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Northwind Pharmaceuticals LLC · 9402 Uptown Dr Ste 1100 · Indianapolis, IN · 46256-1042
Is this the product you have?
- Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only
- Repackaged ByNorthwind Pharmaceuticals, Indianapolis, IN 46256
- NDC51655-950-52
- Lot codes and dates
- Lot
UTB23790003exp 02/28/2019
- Lot
- Amount recalled
- 43 bottles
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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