FDA Drug recall D-0116-2024
8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose Vials (Vial NDC 51754-5001-1
- FDA Drug
- Class I
- ongoing
- Published 2023-11-29
On 2023-11-29 the FDA classified a Class I recall of 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose Vials (Vial NDC 51754-5001-1 by Exela Pharma Sciences, citing presence of Particulate Matter: Silicone.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0116-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-10-18 |
| Published | 2023-11-29 |
| 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 (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
Presence of Particulate Matter: Silicone
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 |
| ndc | 72572-740-01 |
| ndc | 72572-740-20 |
| code_info | a) P0001429, EXP 11/30/2023 b) P0001900, P0001902, EXP 08/31/2024; P0001903, P0001909, P0001945, EXP 09/30/2024; P00020…a) P0001429, EXP 11/30/2023 b) P0001900, P0001902, EXP 08/31/2024; P0001903, P0001909, P0001945, EXP 09/30/2024; P0002002, EXP 11/30/2024; P0002052, EXP 12/31/2024 c) P0001912, EXP 08/31/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0116-2024%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.