Class II · ModerateRecall completed
IRBESARTAN Tablets
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot Numbers: 30-count bottles GS019036; Exp 09/19 GS019073; Exp. 09/19 GS021472; Exp. 11/19 GS021530; Exp. 11/19 GS022234; Exp. 02/20 90-count bottles B162009; Exp. 09/19 B162010; Exp. 09/19 B162011; Exp. 09/19 B162012; Exp. 11/19 B162013; Exp. 11/19 B162014; Exp. 11/19 B162015; Exp. 11/19 C162001; Exp. 02/20
Where it was soldProduct was distributed throughout the United States.
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-nitrosodiethylamine (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 bySciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA
| Distributed by / for | GSMS, Incorporated, Camarillo, CA 93012, USA |
| NDC | 60429-642-30 |
Show the full FDA record
| Full product label | 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: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA. |
| Recalling firm | Golden State Medical Supply Inc. |
| Distribution | Product was distributed throughout the United States. |
| Quantity | 12,502 bottles |
| Recall initiated | 2018-11-02 |
| Report date | 2018-11-28 |
| Recall completed | 2020-09-16 |
| Recall number | D-0265-2019 |
| 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.