Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Exela Pharma Sciences, LLC. | Lenoir, NC, United States | Makes it, tests it and packages it | Serious problems, FDA actionNov 15, 2024 · 12 inspections, 1 with FDA action |
Recalls
- Oct 18, 2023 · Class I · Exela Pharma Sciences LLC
Presence of Particulate Matter: Silicone
Lots: a) P0001429, EXP 11/30/2023 b) P0001900, P0001902, EXP 08/31/2024; P0001903, P0001909, P0001945, EXP 09/30/2024; P0002002, EXP 11/30/2024; P0002052, EXP 12/31/2024 c) P0001912, EXP 08/31/2024 - Nov 28, 2022 · Class I · Exela Pharma Sciences LLC
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Lots: Lot: P0001490 Exp. 12/2023 - Oct 4, 2022 · Class I · Exela Pharma Sciences LLC
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
Lots: Lot #: P0001497 Exp. 12/2023; P0001600 Exp. 02/2024; P0001663 Exp. 03/2024
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Bicarbonate Ion: every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 84 mg per 1 mL
- Approval
- ANDA ANDA211091
- On the market since
- Aug 1, 2019
- Package NDCs
72572-740-25- Official label
- DailyMed (National Library of Medicine), updated Nov 24, 2025
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