Class II · ModerateRecall completed
AvKARE Valsartan and Hydrochlorothiazide 160 mg/12.5 mg tablets
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLots: 17325 Exp. 09/2018; 17856 Exp. 09/2018; 18396 Exp. 09/2018; 18702 Exp. 02/2019; 19020 Exp. 02/2019; 19222 Exp. 02/2019; 20030 Exp. 04/2019; 20381 Exp. 04/2019
Where it was soldNationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
| Distributed by / for | AvKARE, Inc. Pulaski, TN 38478 |
| NDC | 42291-885-90 |
Show the full FDA record
| Full product label | AvKARE Valsartan and Hydrochlorothiazide 160 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-885-90 |
| Recalling firm | Avkare Incorporated |
| Distribution | Nationwide |
| Quantity | 24796 bottles |
| Recall initiated | 2018-07-18 |
| Report date | 2018-09-12 |
| Recall completed | 2020-05-07 |
| Recall number | D-1174-2018 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Pulaski TN United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.