IRBESARTAN Tablets — Class II drug recall D-0265-2019
Terminated recall by Golden State Medical Supply Inc., reported 2018-11-28, distributed nationwide. CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in pro
| Recall number | D-0265-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Golden State Medical Supply Inc., Camarillo, CA, United States |
| Recall initiated | 2018-11-02 |
| Classified | 2018-11-20 |
| Reported by FDA | 2018-11-28 |
| Terminated | 2020-09-16 |
| Distributed | Nationwide (US) |
| Quantity | 12,502 bottles |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 60429-0642-30, 60429-0642-90 |
| Lot numbers | 30-COUNT |
Product
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.
Reason for recall
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0265-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.