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.
Other recalls by Exela Pharma Sciences
- 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose Vial, Rx Only, Manufactured a…
FDA Drug · Class II · 2025-09-17 · Exela Pharma Sciences - 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenous Use Only, Rx Only…
FDA Drug · Class II · 2025-04-02 · Exela Pharma Sciences - ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single Dose Sterile Vials, For Intravenous Infusion Only, R…
FDA Drug · Class I · 2023-11-29 · Exela Pharma Sciences - Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Single-Dose Vial, 25 count carton, Ready to Use For Intravenous…
FDA Drug · Class I · 2023-11-29 · Exela Pharma Sciences - 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, Manufactu…
FDA Drug · Class I · 2022-12-21 · Exela Pharma Sciences
All Exela Pharma Sciences recalls
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.