Class II · ModerateRecall completed
Losartan Potassium
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLots: D21C18 Exp. 09/30/22; E21A28 Exp. 09/30/22; E21C04 Exp. 09/30/22; E21D59 Exp. 09/30/22; G21B65 Exp. 09/30/22; H21A12 Exp. 09/30/22; H21D42 Exp. 09/30/22; K21D19 Exp. 10/31/22; A22A73 Exp. 10/31/22
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- AZIDO Impurity levels observed to be above acceptable limits
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 byVivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu, India foreign manufacturer
| Brand name | LOSARTAN POTASSIUM |
| Generic name | LOSARTAN POTASSIUM |
| Active ingredient(s) | LOSARTAN POTASSIUM |
| Distributed by / for | PD-Rx Pharmaceuticals, Inc. |
| NDC | 72789-163-90 |
Show the full FDA record
| Full product label | Losartan Potassium Tablets, USP 25 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu, India NDC 72789-163-90 UPC 3 72789 16390 1 |
| Recalling firm | PD-Rx Pharmaceuticals, Inc. |
| Distribution | Nationwide |
| Quantity | 1441 bottles |
| Recall initiated | 2022-06-06 |
| Report date | 2022-07-06 |
| Recall completed | 2024-06-17 |
| Recall number | D-1161-2022 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Oklahoma City OK 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.