FDA Drug recall D-0369-2022
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by: Exela Pharma Science…
- FDA Drug
- Class II
- terminated
- Published 2022-01-19
On 2022-01-19 the FDA classified a Class II recall of 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by: Exela Pharma Science… by Exela Pharma Sciences, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0369-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-01-11 |
| Published | 2022-01-19 |
| 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 vials, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC., Lenoir, NC 28645, NDC 51754-5001-1
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | Lot #: C0001088/P0001317, Exp. Date 08/2023 |
|---|
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-0369-2022%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.