Irbesartan and Hydrochlorothiazide Tablets — Class II drug recall D-0413-2019
Completed recall by Prinston Pharmaceutical Inc, reported 2019-02-06, distributed nationwide. CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API us
| Recall number | D-0413-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Prinston Pharmaceutical Inc, Somerset, NJ, United States |
| Recall initiated | 2019-01-18 |
| Classified | 2019-01-27 |
| Reported by FDA | 2019-02-06 |
| Distributed | Nationwide (US) |
| Quantity | 87,505 bottles |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 43547-0330, 43547-0330-03, 43547-0330-09, 43547-0330-50, 43547-0331, 43547-0331-03, 43547-0331-09, 43547-0331-50 |
Product
Irbesartan and Hydrochlorothiazide Tablets, USP 150/12.5 mg Rx 30 Tablets Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zheijang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 NDC 43547-330-03
Reason for recall
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
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-0413-2019. 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.