Class II · ModerateActive recall
Valsartan and Hydrochlorothiazide Tablets
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberExpiry, lot: 1/31/2019: 7293219; 6/30/2019: 7362231, 8074161, 8110184, 8197215, 8114178, 8115123; 9/30/2018: 7132187, 7160161, 7180150, 7268239
Where it was soldNationwide USA
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 | A-S Medication Solutions LLC. |
| NDC | 54569-6488-0 |
Show the full FDA record
| Full product label | Valsartan and Hydrochlorothiazide Tablets, Valsartan 320 MG and Hydrochlorothiazide 25 MG, 90 tablets per bottle, Rx Only, MFG: Arrow Pharm (Malta) LTD, Birzebbugia, BBG 3000 Malta. NDC: 54569-6488-0 |
| Recalling firm | A-S Medication Solutions LLC. |
| Distribution | Nationwide USA |
| Quantity | 531 bottles |
| Recall initiated | 2018-07-17 |
| Report date | 2018-08-29 |
| Recall completed | — |
| Recall number | D-1111-2018 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Libertyville IL 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.