SODIUM BICARBONATE Recall D-0080-2023
Description: 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, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1.
SODIUM BICARBONATE Recall D-0080-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0080-2023 |
| Event ID | 91197 |
| Brand | SODIUM BICARBONATE |
| Generic Name | SODIUM BICARBONATE |
| Manufacturer | SODIUM BICARBONATE |
| Original Package? | 1 |
| Active Substance | SODIUM BICARBONATE |
| Drug Route | INTRAVENOUS |
| Distribution | Nationwide within the United States |
| Quantity | 37,320 vials |
| Recall Reason | Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration. |
| Drug Classification | Class I |
| Drug Code Info | 20221221 |
| Product NDC | 72572-740 |
| Recall Initiation Date | 20221128 |
| Report Date | 20221221 |
| Classification Date | 20221213 |
| Address | 1245 Blowing Rock Blvd Lenoir, NC 28645-3618 United States |
| Recalling Firm | Exela Pharma Sciences LLC |
| Initial Notification | Press Release |
| Unique Ingredient Identifier | 8MDF5V39QO |
| Drug Application Number | ANDA211091 |
| Structured Product Labeling (SPL ID) | a10fdfbc-94a0-49ab-b26c-de1df042bc89 |
| Structured Product Labeling (SPL Set ID) | a10fdfbc-94a0-49ab-b26c-de1df042bc89 |
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