FDA Drug recall D-0022-2023
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, Manufactu…
- 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, Manufactu… 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-0022-2023 |
| 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, Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645. Carton NDC 51754-5001-5, vial NDC 51754-5001-1
Reason
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
Identifiers
| ndc | 51754-5001-5 |
|---|---|
| ndc | 51754-5001-4 |
| ndc | 51754-5011-4 |
| ndc | 51754-5002-5 |
| ndc | 51754-5012-4 |
| ndc | 51754-5001-1 |
| code_info | Lot # : P0001370, P0001371, P0001372, Exp. 10/2023; P0001433, P0001434 Exp. 11/2023; P0001443, P0001468, P0001469, P000…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, P0001572, P0001573, P0001574, P0001578, P0001579, P0001580, P0001583, P0001586, P0001587, P0001588, P0001593, P0001594, P0001610, P0001618, P0001619, P0001654 Exp. 02/2024; P0001644, P0001645, P0001646, P0001662, P0001664 Exp. 03/2024; P0001730 Exp. 05/2024. |
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-0022-2023%22
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