SODIUM BICARBONATE Recall D-0100-2024
Description: 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-5534-24
SODIUM BICARBONATE Recall D-0100-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0100-2024 |
| Event ID | 93124 |
| Brand | SODIUM BICARBONATE |
| Generic Name | SODIUM BICARBONATE |
| Manufacturer | SODIUM BICARBONATE |
| Original Package? | 1 |
| Active Substance | SODIUM BICARBONATE |
| Drug Route | INTRAVENOUS |
| Distribution | Nationwide in the US and Puerto Rico. The products were not distributed to government accounts or foreign consignees. |
| Quantity | 24,900 vials |
| Recall Reason | Presence of Particulate Matter: identified as glass. |
| Drug Classification | Class I |
| Drug Code Info | 20231115 |
| Product NDC | 0409-5534 |
| Recall Initiation Date | 20231002 |
| Report Date | 20231115 |
| Classification Date | 20231109 |
| Address | 235 East 42nd Street New York, NY 10017-5703 United States |
| Recalling Firm | Pfizer Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 8MDF5V39QO |
| Drug Application Number | ANDA202679 |
| Structured Product Labeling (SPL ID) | 84dd5f18-5b16-4181-87c5-fd6cf4df147c |
| Structured Product Labeling (SPL Set ID) | 85ac5491-eb50-4bd1-b5ed-c34457632311 |
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