Drug recall
4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose…
FDA recall event 97348 · Class II · Exela Pharma Sciences LLC
Key facts
| Event ID | 97348 |
|---|---|
| Recall numbers | D-0620-2025 |
| Recalling firm | Exela Pharma Sciences LLC |
| Product type | Drugs |
| Products | 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 and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested. |
| Initiation date | Jul 30, 2025 |
| Report date | Sep 17, 2025 |
| City | Lenoir |
| State | NC |
| Country | United States |
| FEI number | 3008563008 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: