SODIUM BICARBONATE Recall D-0303-2025
Description: 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, Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 28645. NDC Inner Vial: 51754-5001-1; NDC Carton: 51754-5001-4
SODIUM BICARBONATE Recall D-0303-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0303-2025 |
| Event ID | 96481 |
| Brand | SODIUM BICARBONATE |
| Generic Name | SODIUM BICARBONATE |
| Manufacturer | SODIUM BICARBONATE |
| Original Package? | 1 |
| Active Substance | SODIUM BICARBONATE |
| Drug Route | INTRAVENOUS |
| Distribution | Nationwide |
| Quantity | 103,950 vials |
| Recall Reason | Lack of Assurance of Sterility |
| Drug Classification | Class II |
| Drug Code Info | 20250402 |
| Product NDC | 51754-5001 51754-5011 51754-5002 |
| Recall Initiation Date | 20250307 |
| Report Date | 20250402 |
| Classification Date | 20250327 |
| Address | 1245 Blowing Rock BlvdN/A Lenoir, NC 28645-3618 United States |
| Recalling Firm | Exela Pharma Sciences LLC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 8MDF5V39QO |
| Drug Application Number | ANDA211091 |
| Structured Product Labeling (SPL ID) | 4da0ba66-756d-4b4d-8018-81ca16578ef1 |
| Structured Product Labeling (SPL Set ID) | e9698a4f-1a95-4f28-a945-e8009d1d6dd4 |
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