Prinston Pharmaceutical Inc Recall: Irbesartan and Hydrochlorothiazide Tablets, USP 300/12
Prinston Pharmaceutical Inc Recall: Irbesartan and Hydrochlorothiazide Tablets, USP 300/12 is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Prinston Pharmaceutical Inc; Product: Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmace
| Recalling firm | Prinston Pharmaceutical Inc |
|---|---|
| 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 30 count - NDC 43547-331-03 |
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Completed |
| Distribution | Nationwide |
| Recall initiated | 20190118 |
| Recall number | D-0411-2019 |
| Category | drug |
| State | NJ |
| Country | United States |
$29/mo
Try RecallGuard →