Reported Sep 12, 2018 · Terminated
AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE,…
Avkare Incorporated
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 Incorporated · 114 S 1st St · Pulaski, TN · 38478-3216
Is this the product you have?
- AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets, 90-count bottle, Rx Only
- Manufactured forAvKARE, Inc. Pulaski, TN 38478, NDC 42291-884-90
- Lot codes and dates
- Lots
17349 Exp. 08/201818395 Exp. 08/201819221 Exp. 06/201920029 Exp. 06/201920158 Exp. 07/201920843 Exp. 07/201921411 Exp. 09/2019
- Lots
- Amount recalled
- 12240 bottles
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 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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