NDC 51754-5011
Sodium Bicarbonate 84 mg per 1 mL injection, solution
On the label: Exela Pharma Sciences, LLC.
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
- Jul 30, 2025 · Class II · Exela Pharma Sciences LLC
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Lots: Lot # 10004077, Exp. 02/28/2026 - Mar 7, 2025 · Class II · Exela Pharma Sciences LLC
Lack of Assurance of Sterility
Lots: Lots: 10006417 and 10006418, Exp. 11/30/2026 - 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: Lots: P0001178 Exp. 05/2023; P0001298, P0001301, P0001313, P0001314, P0001317 Exp. 08/2023; P0001330, P0001464 Exp. 09/2023; P0001442 Exp. 11/2023; P0001467, P0001472, P0001486, P0001532 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 # : P0001370, P0001371, P0001372, Exp. 10/2023; P0001433, P0001434 Exp. 11/2023; P0001443, P0001468, P0001469, P0001470, P0001495, P0001505, P0001506, P0001509, P0001510, P0001511, P0001512 Exp. 12/2023; P0001560, P0001561, P0001562, P0001564, P0001566, P0001567, P0001568 Exp. 01/2024; P0001571…
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
- Sep 1, 2020
- Package NDCs
51754-5011-4- Official label
- DailyMed (National Library of Medicine), updated Sep 27, 2017
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