Irbesartan Tablets 300 mg 90 count Rx only Manufactured by: Zhejiang… — Class II drug recall D-0409-2019
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-0409-2019 |
|---|---|
| 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 | 19,800 bottles |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 43547-0374, 43547-0374-03, 43547-0374-09, 43547-0374-50, 43547-0375, 43547-0375-03, 43547-0375-09, 43547-0375-50, 43547-0376, 43547-0376-03, 43547-0376-09, 43547-0376-50 |
Product
Irbesartan Tablets 300 mg 90 count Rx only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Xunqiao, Linhai, Zhejiang 317024 China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 NDC 43547-376-09
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
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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.