Class II · ModerateRecall completed
GSMS Irbesartan Tablets
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot number[redacted-phone] Irbesartan 300mg Tablets, 30 Count Bottle GS019036 Sep-19 GS019073 Sep-19 GS021472 Nov-19 GS021530 Nov-19 GS022234 Feb-20 [redacted-phone] Irbesartan 300mg Tablets, 90 Count Bottle B162009 Sep-19 B162010 Sep-19 B162011 Sep-19 B162012 Nov-19 B162013 Nov-19 B162014 Nov-19 B162015 Nov-19 C162001 Feb-20
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: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
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 byScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA
| Distributed by / for | Sciegen Pharmaceuticals Inc |
| NDC | 60429-642-30 |
Show the full FDA record
| Full product label | GSMS Irbesartan Tablets, USP, 300 mg,(a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90), Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA. |
| Recalling firm | Sciegen Pharmaceuticals Inc |
| Distribution | Nationwide |
| Quantity | 30,194 HDPE bottles |
| Recall initiated | 2018-10-29 |
| Report date | 2018-11-28 |
| Recall completed | 2023-09-25 |
| Recall number | D-0272-2019 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Hauppauge NY 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.