Class II · ModerateRecall completed
Losartan Potassium and Hydrochlorothiazide Tablets
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot: 19326 Exp. 03/31/2019
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: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
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 | 50268-514-15 |
Show the full FDA record
| Full product label | Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-514-15 |
| Recalling firm | AVKARE Inc. |
| Distribution | Nationwide. |
| Quantity | N/A |
| Recall initiated | 2019-03-05 |
| Report date | 2019-03-27 |
| Recall completed | 2020-12-07 |
| Recall number | D-1046-2019 |
| 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.