Class II · ModerateRecall completed
Fosinopril Sodium and Hydrochlorothiazide Tablets
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot CU0856
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
Subpotent; Hydrochlorothiazide at the 9 month time point.
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 | Sandoz Inc |
| NDC | 0185-0341-01 |
Show the full FDA record
| Full product label | Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, Rx Only, 100 Tablets, Sandoz Inc. Princeton, NJ 08540 ---NDC 0185-0341-01, |
| Recalling firm | Sandoz Inc |
| Distribution | Nationwide |
| Quantity | 2,491 bottles of 100 tablets each |
| Recall initiated | 2013-10-11 |
| Report date | 2014-01-08 |
| Recall completed | 2015-03-05 |
| Recall number | D-393-2014 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Wilson NC 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.