POTASSIUM CHLORIDE Recall D-0370-2024
Description: Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-1944-20
POTASSIUM CHLORIDE Recall D-0370-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0370-2024 |
| Event ID | 94184 |
| Brand | POTASSIUM CHLORIDE |
| Generic Name | POTASSIUM CHLORIDE |
| Manufacturer | POTASSIUM CHLORIDE |
| Original Package? | 1 |
| Active Substance | POTASSIUM CHLORIDE |
| Drug Route | PARENTERAL |
| Distribution | Nationwide in the USA |
| Quantity | 22,752 bags |
| Recall Reason | Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label, resulting in leaks. |
| Drug Classification | Class II |
| Drug Code Info | 20240320 |
| Product NDC | 0264-1944 |
| Recall Initiation Date | 20240306 |
| Report Date | 20240320 |
| Classification Date | 20240308 |
| Address | 2525 Mcgaw Ave Irvine, CA 92614-5841 United States |
| Recalling Firm | B. Braun Medical Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 660YQ98I10 |
| Drug Application Number | ANDA085870 |
| Structured Product Labeling (SPL ID) | 95c83840-ae78-4210-8b5f-cf4120989811 |
| Structured Product Labeling (SPL Set ID) | ab67b151-8368-4321-b562-bad5eff7b740 |
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