FDA Drug recall D-0023-2023
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:…
- FDA Drug
- Class I
- terminated
- Published 2022-11-02
On 2022-11-02 the FDA classified a Class I recall of 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:… by Exela Pharma Sciences, citing defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0023-2023 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2022-10-04 |
| Published | 2022-11-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Exela Pharma Sciences |
| Distribution | US |
Product
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
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
Identifiers
| code_info | Lot #: P0001497 Exp. 12/2023; P0001600 Exp. 02/2024; P0001663 Exp. 03/2024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0023-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.