FDA Drug recall D-0302-2019
Westminster Irbesartan Tablets, USP 300 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc
- FDA Drug
- Class II
- terminated
- Published 2018-12-19
On 2018-12-19 the FDA classified a Class II recall of Westminster Irbesartan Tablets, USP 300 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc by Westminster Pharmaceuticals, citing CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0302-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-29 |
| Published | 2018-12-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Westminster Pharmaceuticals |
| Distribution | US |
Product
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
Reason
CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.
Identifiers
| code_info | Batch Numbers: a) B162008A Exp. 09/30/2019, C162002A Exp. 02/29/2020; b) B162008B Exp. 09/30/2019, C162002B Exp. 02/29/2020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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FDA Drug · Class II · 2025-08-20 · Westminster Pharmaceuticals - Metoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur,…
FDA Drug · Class II · 2025-08-20 · Westminster Pharmaceuticals - Westminster Irbesartan Tablets, USP 75 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc
FDA Drug · Class II · 2018-12-19 · Westminster Pharmaceuticals - Westminster Irbesartan Tablets, USP 150 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc
FDA Drug · Class II · 2018-12-19 · Westminster Pharmaceuticals - Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1 & 1/2 grain (90 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pha…
FDA Drug · Class I · 2018-08-29 · Westminster Pharmaceuticals
All Westminster Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0302-2019%22
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