Class II · ModerateRecall completed
Westminster Irbesartan Tablets
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberBatch Numbers: a) B162008A Exp. 09/30/2019, C162002A Exp. 02/29/2020; b) B162008B Exp. 09/30/2019, C162002B Exp. 02/29/2020
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: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.
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 Manufactured for: Westminster Pharmaceuticals, LLC. Olive Branch, MS 38654 a) 30 count bottle
| Distributed by / for | Westminster Pharmaceuticals, LLC. Olive Branch, MS 38654 a) 30 count bottle |
| NDC | 69367-121-01 |
Show the full FDA record
| Full product label | Westminster Irbesartan Tablets, USP 300 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: Westminster Pharmaceuticals, LLC. Olive Branch, MS 38654 a) 30 count bottle NDC 69367-121-01; b) 90 count bottle NDC 69367-121-03 |
| Recalling firm | Westminster Pharmaceuticals Llc |
| Distribution | Nationwide. |
| Quantity | 3976 bottles |
| Recall initiated | 2018-10-29 |
| Report date | 2018-12-19 |
| Recall completed | 2021-10-26 |
| Recall number | D-0302-2019 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Olive Branch MS 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.