8 — Class I drug recall D-0116-2024
Ongoing recall by Exela Pharma Sciences LLC, reported 2023-11-29, distributed nationwide. Presence of Particulate Matter: Silicone
| Recall number | D-0116-2024 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exela Pharma Sciences LLC, Lenoir, NC, United States |
| Recall initiated | 2023-10-18 |
| Classified | 2023-11-22 |
| Reported by FDA | 2023-11-29 |
| Distributed | Nationwide (US) |
| Quantity | 355,220 vials |
| Reason classes | specification failure |
| 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, 72572-0740-01, 72572-0740-20 |
| Expiration dates | 2023-11-30, 2024-08-31, 2024-09-30, 2024-11-30, 2024-12-31 |
Product
8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-5) and b) 25x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-4), For Intravenous Use Only, RX Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 28645; ALSO LABELED 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), c) 20x50 mL Single Dose Vials, (Vial NDC 72572-740-01; Carton NDC 72572-740-20), Rx Only, Mfd for: Civica, Inc., Lehi, Utah, 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645.
Reason for recall
Presence of Particulate Matter: Silicone
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-0116-2024. 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.