Severity
Critical
CriticalClass ITerminated
FDA Drug recall · Reported December 21, 2022
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, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1.
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Exela Pharma Sciences LLC recalled 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, p… - a critical-severity action.
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, p… was recalled by Exela Pharma Sciences LLC in December 21, 2022. Reason: Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing t…. Check the official notice for the remedy. Verify recall #D-0080-2023 with the FDA Drug before acting.
The recall
Exela Pharma Sciences LLC issued this critical-severity FDA Drug recall-Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing t….
- Critical
- severity level
- Class I
- classification
- December 21, 2022
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0080-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0080-2023) was formally reported on December 21, 2022, with the manufacturer initiating the action on November 28, 2022. It is classified under Critical severity (Class I), with a current status of Terminated. Exela Pharma Sciences LLC is listed as the recalling firm, operating out of Lenoir, NC. Federal records list the affected scope as 37,320 vials.
The documented reason for this recall is: Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration. Distribution data in the federal record shows the product reached: Nationwide within the United States. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
37,320 vials
Related Recalls
6
5 from same agency
Product description
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, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1.
Reason for recall
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | D-0080-2023 |
| Date reported | December 21, 2022 |
| Date initiated | November 28, 2022 |
| Recalling firm | Exela Pharma Sciences LLC |
| Firm location | Lenoir, NC |
| Affected scope | 37,320 vials |
| Distribution | Nationwide within the United States |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0080-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1.. Recalled by Exela Pharma Sciences LLC. Units affected: 37,320 vials.
Why was this product recalled? ▼
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 21, 2022. Severity: Critical. Recall number: D-0080-2023.
Where was the recalled product distributed? ▼
Distribution: Nationwide within the United States.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0080-2023) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3…
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FDA Drug Moderate
Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, …
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Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported December 21, 2022. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.