Reported Sep 5, 2018 · Terminated
Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-784-15 Manufactured for: AvKARE, Inc.…
AVKARE Inc.
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: AVKARE Inc. · 615 N 1st St · Pulaski, TN · 38478-2403
Is this the product you have?
- Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit
- Dose NDC 50268-784-15 Manufactured forAvKARE, Inc. Pulaski, TN 38478
- Lot codes and dates
- Lots
18492 Exp. 11/201820169 Exp. 05/2019
- Lots
- Amount recalled
- 728 cartons (36,400 tablets)
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
- Nationwide
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.
Want the full recall guide?
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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