CALCIUM CHLORIDE Recall D-1140-2023
Description: DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in a) 2000 mL AMBU-FLEX II Container bag, Product Code L5B4825, NDC 0941-0409-06; b) 5000 mL AMBU-FLEX II Container bag, Product Code L5B4826, NDC 0941-0409-07; and c) 6000 mL AMBU-FLEX II Container bag, Product Code L5B9770, NDC 0941-0409-01, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.
CALCIUM CHLORIDE Recall D-1140-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1140-2023 |
| Event ID | 92931 |
| Brand | DIANEAL LOW CALCIUM WITH DEXTROSE |
| Generic Name | SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE |
| Manufacturer | SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE |
| Original Package? | 1 |
| Active Substance | CALCIUM CHLORIDE DEXTROSE MONOHYDRATE |
| Drug Route | INTRAPERITONEAL |
| Distribution | Nationwide in the USA |
| Quantity | a) 44,520; b) 60,762; c) 483,912 |
| Recall Reason | Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. |
| Drug Classification | Class II |
| Drug Code Info | 20230906 |
| Product NDC | 0941-0409 0941-0411 0941-0413 |
| Recall Initiation Date | 20230811 |
| Report Date | 20230906 |
| Classification Date | 20230829 |
| Address | 1 Baxter Pkwy Deerfield, IL 60015-4625 United States |
| Recalling Firm | Baxter Healthcare Corporation |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 02F3473H9O TU7HW0W0QT |
| Drug Application Number | NDA017512 |
| Structured Product Labeling (SPL ID) | e69de62f-6a6c-4a34-8a81-0e54841f7ec1 |
| Structured Product Labeling (SPL Set ID) | aa268d3f-7389-4f25-801f-5d4825495f08 |
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