FDA Drug recall D-0412-2019
Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd
- FDA Drug
- Class II
- completed
- Published 2019-02-06
On 2019-02-06 the FDA classified a Class II recall of Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd by Prinston Pharmaceutical, citing 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 inta….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0412-2019 |
| Classification | Class II |
| Status | completed |
| Initiated | 2019-01-18 |
| Published | 2019-02-06 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Prinston Pharmaceutical |
| Distribution | US |
Product
Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zheijang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 90 count NDC 43547-331-09
Reason
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.
Identifiers
| ndc | 43547-330-03 |
|---|---|
| ndc | 43547-330-09 |
| ndc | 43547-330-50 |
| ndc | 43547-331-03 |
| ndc | 43547-331-09 |
| ndc | 43547-331-50 |
| code_info | 327B18008 327B18009 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0412-2019%22
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