NDC 71335-2168
Irbesartan 150 mg tablet
On the label: Bryant Ranch Prepack. It's repackaged: Bryant Ranch Prepack rebottles it from Solco Healthcare U.S., LLC's NDC 43547-375.
Where the pills inside were 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 |
Repackaging site
- Bryant Ranch Prepack, Burbank, CA, United States · repackages it and relabels it
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
- 150 mg
- Approval
- ANDA ANDA203071
- On the market since
- Jun 13, 2016
- Package NDCs
71335-2168-171335-2168-271335-2168-3- Official label
- DailyMed (National Library of Medicine), updated Nov 27, 2023
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