SODIUM BICARBONATE Recall D-0116-2024
Description: 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.
SODIUM BICARBONATE Recall D-0116-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0116-2024 |
| Event ID | 93265 |
| Brand | SODIUM BICARBONATE |
| Generic Name | SODIUM BICARBONATE |
| Manufacturer | SODIUM BICARBONATE |
| Original Package? | 1 |
| Active Substance | SODIUM BICARBONATE |
| Drug Route | INTRAVENOUS |
| Distribution | Nationwide |
| Quantity | 355,220 vials |
| Recall Reason | Presence of Particulate Matter: Silicone |
| Drug Classification | Class I |
| Drug Code Info | 20231129 |
| Product NDC | 51754-5001 51754-5011 51754-5002 |
| Recall Initiation Date | 20231018 |
| Report Date | 20231129 |
| Classification Date | 20231122 |
| Address | 1245 Blowing Rock Blvd 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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