NDC 51662-1399
Bupivacaine Hci And Epinephrine 5 mg per 1 mL / 0.005 mg per 1 mL injection, solution
On the label: HF Acquisition Co. LLC. DBA HealthFirst. It's repackaged: HF Acquisition Co. LLC. DBA HealthFirst rebottles it from Fresenius Kabi, LLC's NDC 63323-463.
Where the pills inside were 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 |
Repackaging site
- HF Acquisition Co LLC, Mukilteo, WA, United States · relabels it
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 and Epinephrine: every company that makes it
- Form
- injection, solution, perineural
- Strength
- 5 mg per 1 mL / 0.005 mg per 1 mL
- Approval
- ANDA ANDA070968
- On the market since
- Dec 9, 2019
- Package NDCs
51662-1399-151662-1399-251662-1399-3- Official label
- DailyMed (National Library of Medicine), updated Jan 30, 2024
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