Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Lupin Limited | Pithampur, India | Makes it | Serious problems, FDA actionJul 17, 2025 · 6 inspections, 4 with FDA action |
Recalls
- Oct 12, 2021 · Class II · Lupin Pharmaceuticals Inc.
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Lots: a) Lot# H000843, exp. date 28/02/2023 H805727, exp. date 30/11/2021 H901579, exp. date 31/03/2022 b) Lot# H000844, exp. date 28/02/2023 H000964, exp. date 31/03/2023 H804311, exp. date 31/08/2021 H805267, exp. date 30/11/2021 H805268, exp. date 30/11/2021 H805269, exp. date 30/11/20… - Oct 12, 2021 · Class II · Lupin Pharmaceuticals Inc.
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Lots: a) Lot# H804403, exp. date 31/08/2021 H805251, exp. date 30/11/2021 H805640, exp. date 30/11/2021 H901580; exp. date 30/04/2022 b) Lot# H804492, exp. date 31/08/2021 H805252, exp. date 30/11/2021 H805253, exp. date30/11/2021 H805641, exp. date30/11/2021 H805642, exp. date30/11/2021 … - Oct 12, 2021 · Class II · Lupin Pharmaceuticals Inc.
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Lots: a) Lot# H804310, exp. date 31/08/2021 H900050, exp. date 30/11/2021 H902262, exp. date 31/05/2022 b) Lot# H000845, exp. date 28/02/2023 H000846, exp. date 28/02/2023 H000965, exp. date 31/03/2023 H805345, exp. date 30/11/2021 H805346, exp. date 30/11/2021 H805347, exp. date 30/11/20…
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 ANDA201531
- On the market since
- Oct 23, 2012
- Package NDCs
68180-412-0268180-412-0668180-412-09- Official label
- DailyMed (National Library of Medicine), updated Nov 22, 2023
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