Food, drugs, devices › Exela Pharma Sciences LLC
Drug recall: 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials,
Exela Pharma Sciences LLC (Lenoir, NC) initiated this drug recall on 28 Nov 2022; FDA lists 2 product records under event 91197, classified Class I.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 18% of the 325 drug enforcement events initiated in 2022 carry the same class.
Status: Terminated, terminated 10 Oct 2025. Initiation: voluntary: firm initiated. Exela Pharma Sciences LLC has 8 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Exela Pharma Sciences LLC, Lenoir, NC.
Reason for recall
"Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration."
Distribution
"Nationwide within the United States"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0079-2023 | 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. | 489,600 vials | Class I | Terminated | 21 Dec 2022 |
| D-0080-2023 | 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. | 37,320 vials | Class I | Terminated | 21 Dec 2022 |
Context
Other enforcement events for Exela Pharma Sciences LLC
All 8 events for Exela Pharma Sciences LLC
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide within the United States"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 10 Oct 2025. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.