Class II · ModerateActive recall
LOSARTAN POTASSIUM TABLETS
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot number1178533A, 1178534A, 1178535A, 1178536A, 1178537A, 1178538A, 1178539A, 1178540A, 1178541A, 1178542A, 1178543A, 1178544A, 1178545A, 1178546A exp 03/2020
Where it was soldBulk product was distributed to one re-packager in California.
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
Made byArrow Pharma (Malta) Ltd., Birzebbugia, Malta
| Distributed by / for | Teva Pharmaceuticals USA |
| NDC | 0591-3747-00 |
Show the full FDA record
| Full product label | LOSARTAN POTASSIUM TABLETS, USP 100 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia, Malta NDC 0591-3747-00 |
| Recalling firm | Teva Pharmaceuticals USA |
| Distribution | Bulk product was distributed to one re-packager in California. |
| Quantity | N/A |
| Recall initiated | 2020-03-25 |
| Report date | 2020-04-15 |
| Recall completed | — |
| Recall number | D-1102-2020 |
| 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.