GSMS Irbesartan Tablets — Class II drug recall D-0270-2019
Terminated recall by Sciegen Pharmaceuticals Inc, reported 2018-11-28, distributed nationwide. CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in pr
| Recall number | D-0270-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sciegen Pharmaceuticals Inc, Hauppauge, NY, United States |
| Recall initiated | 2018-10-29 |
| Classified | 2018-11-20 |
| Reported by FDA | 2018-11-28 |
| Terminated | 2023-09-25 |
| Distributed | Nationwide (US) |
| Quantity | 3,835 hdpe |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 60429-0640-90 |
Product
GSMS Irbesartan Tablets, USP, 75 mg, 30-count bottle, Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Marketed by: GSMS Incorporated Camarillo, CA 93012 USA, NDC 60429-640-90.
Reason for recall
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (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-0270-2019. 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.