SODIUM CHLORIDE Recall D-0076-2023
Description: 0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862
SODIUM CHLORIDE Recall D-0076-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0076-2023 |
| Event ID | 91194 |
| Brand | SODIUM CHLORIDE |
| Generic Name | SODIUM CHLORIDE |
| Manufacturer | SODIUM CHLORIDE |
| Original Package? | 1 |
| Active Substance | SODIUM CHLORIDE |
| Drug Route | INTRAVENOUS |
| Distribution | FL, NJ, PA |
| Quantity | 756 bags |
| Recall Reason | Lack of sterility assurance: Bags have the potential to leak. |
| Drug Classification | Class II |
| Drug Code Info | 20221214 |
| Product NDC | 0264-5802 0264-5804 |
| Recall Initiation Date | 20221125 |
| Report Date | 20221214 |
| Classification Date | 20221205 |
| Address | 901 Marcon Blvd Allentown, PA 18109-9512 United States |
| Recalling Firm | B. Braun Medical, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 451W47IQ8X |
| Drug Application Number | NDA019635 |
| Structured Product Labeling (SPL ID) | d34ea9bc-a1f9-402a-97cf-894505cee75d |
| Structured Product Labeling (SPL Set ID) | e44c41ae-c9c8-4dd8-ba6c-cebb585378aa |
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