Class II · ModerateActive recall
LOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberArrow Malta (Teva) Bulk Product Lot # 1163892A, exp. date 01/2020 1163893A, exp. date 01/2020 1163894A, exp. date 01/2020 1163895A, exp. date 01/2020 Golden State Medical Finished Product Lot # GS017042, exp. date 01/2020 GS017043, exp. date 01/2020 GS017044, exp. date 01/2020 GS017541, exp. date 01/2020
Where it was soldNationwide by 4 major distributors.
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: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
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 | Teva Pharmaceuticals USA |
| NDC | 00591-3747-00 |
Show the full FDA record
| Full product label | LOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles, NDC 00591-3747-00 |
| Recalling firm | Teva Pharmaceuticals USA |
| Distribution | Nationwide by 4 major distributors. |
| Quantity | 2,943,000 tablets |
| Recall initiated | 2019-06-06 |
| Report date | 2019-07-17 |
| Recall completed | — |
| Recall number | D-1456-2019 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Parsippany NJ 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.