8 — Class II drug recall D-0369-2022
Terminated recall by Exela Pharma Sciences LLC, reported 2022-01-19, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0369-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exela Pharma Sciences LLC, Lenoir, NC, United States |
| Recall initiated | 2022-01-11 |
| Classified | 2022-01-13 |
| Reported by FDA | 2022-01-19 |
| Terminated | 2022-12-02 |
| Distributed | Nationwide (US) |
| Quantity | 18,960 vials |
| Reason classes | sterility |
| NDC | 51754-5001-01 |
| Lot numbers | C0001088/P0001317 |
| Expiration dates | 2023-08 |
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 for recall
Lack of Assurance of Sterility
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0369-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.