Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi USA, LLC | Melrose Park, IL, United States | Makes it and tests it | Problems found, fixed voluntarilyAug 24, 2023 · 13 inspections, 2 with FDA action |
Recalls
- Dec 10, 2020 · Class II · Fresenius Kabi USA, LLC
Subpotent Drug: Low out-of-specification assay results for the epinephrine component.
Lots: Batch # 6123760, Exp 02/2022
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, solution, epidural; intracaudal; perineural
- Strength
- 5 mg per 1 mL
- Approval
- ANDA ANDA070553
- On the market since
- Nov 19, 2010
- Package NDCs
63323-466-0863323-466-38- Official label
- DailyMed (National Library of Medicine), updated Nov 18, 2024
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