8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx only, Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645. Carton NDC 51754-5001-5, vial NDC 51754-5001-1.
Drug Recall
Official source record
- Recall number
- D-0079-2023
- Event ID
- 91197
- Classification
- Class I
- Status
- Terminated
- Recalling company
- Exela Pharma Sciences LLC
- Reason for recall
- Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
- Report date
- December 21, 2022
- Recall initiation date
- November 28, 2022
- Termination date
- October 10, 2025
- Distribution pattern
- Nationwide within the United States
Drug product identifiers
- Manufacturer
- Exela Pharma Sciences, LLC
- Brand name
- SODIUM BICARBONATE
- Generic name
- SODIUM BICARBONATE
- Substance name
- SODIUM BICARBONATE
- Product NDCs
- 51754-5001; 51754-5002; 51754-5011; 51754-5012
- Package NDCs
- 51754-5001-1; 51754-5001-4; 51754-5001-5; 51754-5002-5; 51754-5011-4; 51754-5012-4
- Route
- INTRAVENOUS
Where this information comes from
View FDA enforcement record -- the specific openFDA drug enforcement record this summary was built from.
FDA Enforcement Reports -- FDA's general, official recall and enforcement information.
Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for details.
Retrieved by Public Health Trace:
Frequently asked questions
What does a Class I mean?
A situation in which there is a reasonable probability that use of or exposure to a product will cause serious adverse health consequences or death.
Is this recall still active?
According to the FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.
What should I do if I have this medication?
Do not start, stop, or change any medication based on this page. Follow the instructions published by the FDA and the recalling company (see the source links below), and talk to your pharmacist or physician if you have questions about a specific medication.
Where can I find more official information?
The source links below, published by the FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.
Public Health Trace republishes official FDA drug recall information -- it is not affiliated with the FDA, does not verify or supplement what the source has published, and does not provide medical advice. Never start, stop, or change a medication based on this page. Always follow the guidance of your pharmacist or physician, and consult the official source links above for the most current information. Read the full medical disclaimer.
