Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Zhejiang Huahai Pharmaceutical Co., Ltd. | Linhai, China | Makes it | Serious problems, FDA actionApr 24, 2026 · 8 inspections, 3 with FDA action |
Recalls
- Jan 18, 2019 · Class II · Prinston Pharmaceutical Inc
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.
Lots: 331B18009
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Irbesartan: every company that makes it
- Form
- tablet, oral
- Strength
- 300 mg
- Approval
- ANDA ANDA203071
- On the market since
- Jun 13, 2016
- Package NDCs
43547-376-0343547-376-0943547-376-50- Official label
- DailyMed (National Library of Medicine), updated Sep 30, 2025
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