Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Huons Co., Ltd. | Jecheon-si, South Korea | Makes it | Serious problems, FDA actionNov 21, 2025 · 3 inspections, 1 with FDA action |
Recalls
- Apr 2, 2026 · Class II · Huons Co., Ltd.
Lack of Assurance of Sterility
Lots: All lots within expiry
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Bupivacaine: every company that makes it
- Form
- injection, subarachnoid
- Strength
- 7.5 mg per 1 mL
- Approval
- ANDA ANDA212822
- On the market since
- Dec 30, 2019
- Package NDCs
73293-0002-173293-0002-2- Official label
- DailyMed (National Library of Medicine), updated Nov 20, 2024
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