Class II · ModerateRecall completed
Losartan Potassium Tablets
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot Code: GS018406, Exp. Date 6/30/2020; GS018858, Exp. Date 7/31/2020; GS019108, Exp. Date 7/31/2020; GS018521, Exp. Date 7/31/2020; GS018605, Exp. Date 7/31/2020; GS018911, Exp. Date 7/31/2020
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: Impurity for N-nitroso-N-methyl-4-aminobutryric Acid (NBMA) detected in active 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 Pharm (Malta) Ltd., Packaged by GSMS Incorporated, Camarillo, CA 93012, USA
| Distributed by / for | Golden State Medical Supply Inc. |
| NDC | 60429-316-30 |
Show the full FDA record
| Full product label | Losartan Potassium Tablets, USP, 25 mg, Rx only, a) 30 ct. (NDC 60429-316-30) b) 90ct. (NDC 60429-316-90) c) 1,000 ct. (60429-316-10) bottles, GSMS Incorporated, Manufactured by Arrow Pharm (Malta) Ltd., Packaged by GSMS Incorporated, Camarillo, CA 93012, USA |
| Recalling firm | Golden State Medical Supply Inc. |
| Distribution | Nationwide |
| Recall initiated | 2020-04-03 |
| Report date | 2020-04-22 |
| Recall completed | 2020-10-08 |
| Recall number | D-1238-2020 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Camarillo CA 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.