SODIUM CHLORIDE Recall D-0347-2023
Description: 0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-10
SODIUM CHLORIDE Recall D-0347-2023 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0347-2023 |
Event ID | 91658 |
Brand | SODIUM CHLORIDE |
Generic Name | SODIUM CHLORIDE |
Manufacturer | SODIUM CHLORIDE |
Original Package? | 1 |
Active Substance | SODIUM CHLORIDE |
Drug Route | INTRAVENOUS |
Distribution | USA Nationwide. |
Quantity | 483,229 bags |
Recall Reason | Lack of sterility assurance: leaking bags. |
Drug Classification | Class II |
Drug Code Info | 20230301 |
Product NDC | 0264-5802 0264-5804 |
Recall Initiation Date | 20230210 |
Report Date | 20230301 |
Classification Date | 20230223 |
Address | 1845 Mason Ave Daytona Beach, FL 32117-5102 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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