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
- Nov 22, 2022 · Class II · Fresenius Kabi USA, LLC
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Lots: Batch #: 6128061, exp 03/2024; 6128663, 6128664, exp 05/2024 - Nov 22, 2022 · Class II · Fresenius Kabi USA, LLC
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Lots: Batch #: 6128399, 6128400, 6128401, exp 04/2024 - Nov 22, 2022 · Class II · Fresenius Kabi USA, LLC
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Lots: Batch #: 6128800, exp 12/2023 - Apr 25, 2016 · Class II · Fresenius Kabi USA, LLC
Presence of Particulate Matter: Glass particulate found in sterile injectable product
Lots: Lot #: 6111504, Exp 09/2019
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; retrobulbar
- Strength
- 7.5 mg per 1 mL
- Approval
- ANDA ANDA070554
- On the market since
- Nov 19, 2010
- Package NDCs
63323-472-0163323-472-0363323-472-1763323-472-37- Official label
- DailyMed (National Library of Medicine), updated Apr 30, 2023
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