SODIUM BICARBONATE Recall D-0233-2024
Description: 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJECT Unit of Use Syringe, For Intravenous Use, Rx Only, 10 mL Syringe per Carton, Hospira, Inc., Lake Forst, IL 60045, NDC 0409-5534-24 (carton), 0409-5534-14 (case).
SODIUM BICARBONATE Recall D-0233-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0233-2024 |
| Event ID | 93681 |
| Brand | SODIUM BICARBONATE |
| Generic Name | SODIUM BICARBONATE |
| Manufacturer | SODIUM BICARBONATE |
| Original Package? | 1 |
| Active Substance | SODIUM BICARBONATE |
| Drug Route | INTRAVENOUS |
| Distribution | Nationwide in the USA and Puerto Rico. |
| Quantity | 34000 Cartons |
| Recall Reason | Presence of Particulate Matter; identified as glass |
| Drug Classification | Class I |
| Drug Code Info | 20240124 |
| Product NDC | 0409-5534 |
| Recall Initiation Date | 20231221 |
| Report Date | 20240124 |
| Classification Date | 20240117 |
| 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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