8 — Class I drug recall D-0022-2023
Terminated recall by Exela Pharma Sciences LLC, reported 2022-11-02, distributed nationwide. Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing th
| Recall number | D-0022-2023 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exela Pharma Sciences LLC, Lenoir, NC, United States |
| Recall initiated | 2022-10-04 |
| Classified | 2022-10-27 |
| Reported by FDA | 2022-11-02 |
| Terminated | 2025-10-10 |
| Distributed | Nationwide (US) |
| Quantity | 2,123,040 vials |
| Reason classes | foreign material, packaging, device malfunction |
| NDC | 51754-5001, 51754-5001-01, 51754-5001-04, 51754-5001-05, 51754-5002, 51754-5002-05, 51754-5011, 51754-5011-04, 51754-5012, 51754-5012-04 |
| Lot numbers | P0001370, P0001371, P0001372, P0001433, P0001434, P0001443, P0001468, P0001469, P0001470, P0001495, P0001505, P0001506, P0001509, P0001510, P0001511, P0001512, P0001560, P0001561, P0001562, P0001564, P0001566, P0001567, P0001568, P0001571, P0001572, P0001573, P0001574, P0001578, P0001579, P0001580, P0001583, P0001586, P0001587, P0001588, P0001593, P0001594, P0001610, P0001618, P0001619, P0001644 and 6 more |
| Expiration dates | 2023-10, 2023-11, 2023-12, 2024-01, 2024-02, 2024-03, 2024-05 |
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 for recall
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
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-0022-2023. 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.