Reported Sep 5, 2018 · Terminated
Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit Dose 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 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10)
- Unit Dose Manufactured forAvKARE, Inc. Pulaski, TN 38478
- Lot codes and dates
- Lots
18491 Exp. 10/201819531 Exp. 04/201920168 Exp. 05/201920671 Exp. 08/201921049 Exp. 10/201921635 Exp. 10/2019
- Lots
- Amount recalled
- 6776 cartons (338,800 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.
Free recall alerts
Get alerted about new AVKARE Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.